Gynecologic clinical studies

Find insights into the performance, safety, and patient outcomes of gynecologic procedures and technologies.



Noventa M, Ancona E, Quaranta M, Vitagliano A, Cosmi E, D'Antona D, Gizzo S. Intrauterine morcellator devices: The icon of hysteroscopic future or merely a marketing image? A systematic review regarding safety, efficacy, advantages, and contraindications. Reprod Sci. 2015 Oct;22(10):1289–1296. 


A review of all available evidence pertaining to the use of intrauterine morcellators (IUM) was conducted to compare IUM systems to traditional resectoscopy and outpatient operative hysteroscopy, inclusive of 1,185 patients. The available evidence allows us to consider IUM devices —  such as the TruClear™ system —  as a safe, effective, and cost‑effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. 



AlHilli MM, Nixon KE, Hopkins MR, Weaver AL, Laughlin-Tommaso SK, Famuyide AO. Long-term outcomes after intrauterine morcellation versus hysteroscopic resection of endometrial polyps. J Minim Invasive Gynecol. 2013 Mar–Apr;20(2):215–221.


This study concludes that compared with electrical resection, Intrauterine Morcellation (IUM) may be associated with lower recurrence of endometrial polyps. However, the incidence of recurrent abnormal uterine bleeding (AUB) is independent of polypectomy method. This article also notes that there were no reports of inability to establish a histopathologic diagnosis among all pathology specimens evaluated.



Pampalona JR, Bastos MD, Moreno GM, Pust AB, Montesdeoca GE, Guerra Garcia A, et.al. A comparison of hysteroscopic mechanical tissue removal with bipolar electrical resection for the management of endometrial polyps in an ambulatory care setting: preliminary results. J Minim Invasive Gynecol. 2015 Mar–Apr;22(3):439–445.


This study was designed to compare efficacy, pain, and the learning curve associated with the treatment of polypectomies using the TruClear™ system versus bipolar electrical resection in an ambulatory care setting. If a successful procedure is predicated on access to cavity, visualization, and complete resection and excision of endometrial polyp, the TruClear™ system shows a higher success rate than the Versapoint™* bipolar electrosurgery system at 92 percent and 77 percent, respectively.



Van Dongen H, Emanuel MH, Wolterbeek R, Trimbos JB, Jansen FW. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: A randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008 Jul–Aug;15(4):466–471.


This study showed operating time was reduced more than 6 minutes (p=0.008) when using the TruClear™ system compared to conventional resectoscopy. Subjective surgeon and trainer scores for convenience of technique on a visual analog scale were in favor of the TruClear™ system. In conclusion, the TruClear™ system offers a good alternative to conventional resectoscopy for residents in training.



Emanuel MH. New developments in hysteroscopy. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):421–429.


Diagnostic and operative hysteroscopy have become standards in gynaecologic practice, and many hysteroscopic procedures have replaced old, invasive techniques, such as dilatation and curettage. The publication notes that the introduction of hysteroscopic tissue removal opens the option of hysteroscopic surgery for the majority of patients — without the need for extensive training and experience for the gynaecologists. 



Smith PP, Middleton LJ, Connor M, Clark TJ. Hysteroscopic morcellation compared with electrical resection of endometrial polyps: A randomized controlled trial. Obstet Gynecol. 2014 Apr;123(4):745–751.


This study evaluated whether mechanical hysteroscopic tissue removal using the TruClear™ system or bipolar electrosurgical resection is more favorable for removing endometrial polyps in an office setting — in terms of feasibility, speed, pain, and acceptability. It concluded that, in comparison to electrosurgical resection during hysteroscopic polypectomy, mechanical tissue removal was quicker, less painful, more acceptable to women, and more likely to completely remove endometrial polyps. 



Hamerlynck TW, van Vliet HA, Beerens AS, Weyers S, Schoot BC. Hysteroscopic morcellation versus loop resection for removal of placental remnants: A randomized trial. J Minim Invasive Gynecol. 2016 Nov–Dec;23(7):1172–1180.


This study compares mechanical hysteroscopic resection with the TruClear™ system with loop resection for the removal of placental remnants with respect to time, adverse events, tissue availability, histology results, short‑term effectiveness, and postoperative adhesions. Mechanical hysteroscopic tissue resection demonstrated a faster operating time than loop resection. Both techniques are safe and show high rates of complete removal and tissue availability and low rates of de novo intrauterine adhesions.



Hamerlynck TW, Schoot BC, Van Vliet HA, Weyers S. Removal of endometrial polyps: Hysteroscopic morcellation versus bipolar resectoscopy, a randomized trial. J Minim Invasive Gynecol. 2015 Nov–Dec;22(7):1237–1243.


This study compares two methods for removing endometrial polyps: hysteroscopic morcellation and bipolar resectoscopy. In a randomized controlled trial of 84 women, hysteroscopic morcellation was found to be significantly faster, reducing operating time by about 38% (p = .028). Both techniques were similarly effective in completely removing polyps and providing tissue for analysis. However, hysteroscopic morcellation required fewer instrument insertions and showed fewer complications, such as uterine perforation. Overall, the study concludes that hysteroscopic morcellation is a safe, and effective alternative to bipolar resectoscopy for the removal of endometrial polyps.



Wagenaar LP, Hamerlynck TW, Radder CM, Peters LW, Weyers S, Schoot BC, et.al. Hysteroscopic morcellation versus. curettage for removal of retained products of conception: A multicenter randomized controlled trial. Fertil Steril. 2023 Dec;120(6):1243–1251.


Retained products of conception (RPOC) occur after up to 1 in 17 pregnancies. When expectant or medical treatment fails in symptomatic patients, surgical removal is indicated. While vacuum aspiration is widely used, complications such as adhesion formation may lead to subsequent future infertility. Hysteroscopic removal (HR) allows selective treatment of RPOC under “visual control” with a subsequent reduction in possible complications to the adjacent endometrium.



López-Carral JM, Novo AF, Iglesias AF, et al. Hysteroscopic endometrial polypectomy: Comparative retrospective study of the morcellator system versus electrosurgical Resection. 2019 Report. Gynecol Surg. 2(1):22–27.


This study compares hysteroscopic morcellation with electrosurgical resection for removing endometrial polyps in 190 patients. Both methods were equally effective, achieving 100% complete removal with no significant complications. However, morcellation had a significantly shorter surgical time (about 11.9 minutes versus. 15.4 minutes, p<0.001). Overall, hysteroscopic morcellation was associated with a faster surgical time and equally safe alternative to electrosurgical resection for treating endometrial polyps.









Hamerlynck TW, Blikkendaal MD, Schoot BC, Hanstede MM, Jansen FW. An alternative approach for removal of placental remnants: Hysteroscopic morcellation. J Minim Invasive Gynecol. 2013 Nov–Dec;20(6):796–802.


This study concludes that hysteroscopic tissue removal seems to be an effective technique for the management of placental remnants, with complete removal in 94.3 percent of patients. The TruClear™ system may reduce the need for additional removal procedures.



Tam T, Placek J, Juarez L. Hysteroscopic evacuation of retained products of conception. J Obstet Gynaecol. 2016 Nov;36(8):1004–1005.


A case review of a 40‑year‑old, gravida 1, para 0, infertile patient with endometriosis and adenomyosis sent to the Emergency Department for vaginal bleeding. Operative hysteroscopy utilizing the TruClear™ hysteroscopic tissue removal system was performed to successfully evacuate gestational products.



Young S, Miller CE. Hysteroscopic resection for management of early pregnancy loss: A case report and literature review. F S Rep. 2022 Mar 10;3(2):163–167.


This article presents a case report and review on using hysteroscopic resection to manage early pregnancy loss. The case showed successful removal of pregnancy tissue with no complications and a normal uterine cavity afterward. Compared to traditional dilation and curettage (D&C), hysteroscopic resection allows direct visualization, leading to more cases of complete tissue removal, fewer cases of intrauterine adhesions, and a quicker return to fertility. Overall, the study suggests hysteroscopic resection is a safe and effective alternative for surgical management of early pregnancy loss, though more research is needed on long-term outcomes.



Weinberg S, Pansky M, Burshtein I, Beller U, Goldstein H, Barel O. A Pilot Study of guided conservative hysteroscopic evacuation of early miscarriage. J Minim Invasive Gynecol. 2021 Nov;28(11):1860–1867.


This pilot study evaluated the safety and feasibility of hysteroscopic morcellation for treating early miscarriage in 10 women. The procedure successfully achieved complete uterine evacuation in all cases, with no major complications and normal follow-up results. Overall, the technique appears to be a safe and effective alternative to traditional methods, offering the advantage of direct visualization, but larger studies are needed to confirm its benefits.



Hamerlynck TW, Van Vliet HA, Beerens AS, Weyers S, Schoot BC. Hysteroscopic morcellation versus loop resection for removal of placental remnants: A randomized trial. J Minim Invasive Gynecol. 2016 Nov-Dec;23(7):1172–1180.


This randomized trial compared hysteroscopic morcellation and loop resection for removing placental remnants. It found that morcellation was associated with significantly faster operating time, while both methods were equally safe and effective, with high rates of complete removal and low complication and adhesion rates. Overall, hysteroscopic treatment is a faster alternative to traditional methods.



Casadio P, Ambrosio M, Verrelli L, Salucci P, Arena A, Seracchioli R. Conservative cesarean scar pregnancy treatment: Local methotrexate injection followed by hysteroscopic removal with hysteroscopic tissue removal system. Fertil Steril. 2021 Nov;116(5):1417–1419


Primary local methotrexate injection followed by hysteroscopic removal of the cesarean scar pregnancy (CSP) remnants with the hysteroscopic tissue removal system may be a valuable treatment for women who desire pregnancy in the near future. This combined technique may avoid potential complications, such as thermal-induced myometrial injuries or uterine perforation. Moreover, the operator has the possibility to perform an under-vision procedure with a lower incidence of intraoperative and postoperative bleeding. Because it does not reduce fertility/pregnancy rate, this technique should be a valid option in patients who desire future pregnancy.  



Jakopič Maček K, Blaganje M, Kenda Šuster N, Drusany Starič K, Kobal B. Office hysteroscopy in removing retained products of conception - a highly successful approach with minimal complications. J Obstet Gynaecol. 2020 Nov;40(8):1122–1126.


This study evaluated office hysteroscopy (OH) for removing retained products of conception (RPOC) in 101 patients. The procedure was highly successful (93%), safe, and well tolerated, with low pain levels and low complication rate. Most patients avoided general anesthesia. Larger tissue size and irregular tissue attachment made procedures more difficult, but overall, OH is an effective outpatient method for treating RPOC with low risk.



Hamerlynck TW, Dietz V, Schoot BC. Clinical implementation of the hysteroscopic morcellator for removal of intrauterine myomas and polyps. A retrospective descriptive study. Gynecol Surg. 2011 May;8(2):193–196.


This study concludes that in the authors’ experience, hysteroscopic morcellation is a fast, safe, and easy method for removal of polyps and smaller type 0 and 1 myomas. It also notes that there was no significant intraoperative or postoperative bleeding documented during the study. Prospective data are needed to confirm these findings.




AlHili M.M., Hopkins M.R., Shannon L.K., Famuyide A.O. J Minim Invasive Gynecol. 2010;17(6), S38.


While using the TruClear™ system, this study concluded that the diagnosis of morcellated intrauterine specimens is no different from that of specimens obtained via hysteroscopic resection.



Pakrashi T, Ressler IB, Sroga JM, DiPaola KB, Thomas MA, Lindheim SR. Hysteroscopic enucleation of type II submucosal uterine leiomyomas using a TrueClear™ hysteroscopic morcellator: Case report and review of the literature. J Laparoendosc Adv Surg Tech A. 2013 Apr;23(4):378–382. 


This case report describes the surgical principles that guided a complete enucleation of a Type II leiomyoma using the TruClear™ system. Postoperatively, sonohysterography showed complete closure of the dead space with only a slightly distorted endometrial cavity. This report is an example of how the TruClear™ system may allow for complete enucleation during hysteroscopic resection of Type II leiomyoma(s) at the hands of an experienced surgeon



Emanuel MH, Wamsteker K. The intra uterine morcellator: A new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol. 2005 Jan-Feb;12(1):62–66.


When compared with conventional monopolar resection, the TruClear™ system was faster in operating time, and appears easier to use. This article suggests it may result in fewer fluid‑related complications and a shorter learning curve when compared with conventional resectoscopy.



Meulenbroeks D, Hamerlynck TW, Saglam-Kara S, Van Rijssel NK, Van Vliet HA, Schoot BC. Hysteroscopic tissue removal systems: A randomized in vitro comparison. J Minim Invasive Gynecol. 2017 Jan 1;24(1):159–164.


An in vitro comparison of the removal of analogue polyp tissue demonstrated that the larger TruClear™ INCISOR™* plus device (TruClear™ soft tissue shaver plus), MyoSure™* classic and MyoSure™* lite devices were significantly (p < .001) faster than the TruClear™ INCISOR™* device (TruClear™ soft tissue shaver mini) for removal of one polyp, only the TruClear™ INCISOR™* plus device (TruClear™ soft tissue shaver plus) was consistently faster than the TruClear™ INCISOR™* device (TruClear™ soft tissue shaver mini) for the removal of more than one polyp. The performance of the MyoSure™* lite decreased significantly (p < .001) during removal of three consecutive tissue samples. For the removal of myoma tissue, the resection rate of the TruClear™ ultra plus device (TruClear™ dense tissue shaver plus) was significantly higher than that of the MyoSure™* XL, with a decrease in MyoSure™* XL’s resection rate seen with an increase in the fibroid volume when adjusted for vacuum setting.



Vitale SG, Sapia F, Rapisarda AMC, Valenti G, Santangelo F, Rossetti D, et.al. Hysteroscopic morcellation of submucous myomas: A systematic review. Biomed Res Int. 2017;2017:6848250. 


This systematic review evaluated hysteroscopic tissue removal systems (morcellators) for treating submucous myomas. Based on eight studies (283 patients), morcellation was found to be a safe and feasible option with comparable effectiveness and complication rates to traditional resectoscopy. Some studies showed shorter operative times for hysteroscopic tissue removal systems when compared to traditional resectoscopy, whereas others showed no significant difference. The technique works best for smaller (type 0 and 1) myomas, while larger or more complex (type 2) cases remain more challenging. Overall, morcellation is a promising but still limited-evidence alternative requiring further research.



Kavoussi SK, Esqueda AS, West BT, Chen SH, London K, Lebovic DI,et.al. The effects of hysteroscopic morcellation of endometrial polyps on frozen embryo transfer outcomes. Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:241–244. 


This retrospective study evaluated whether hysteroscopic morcellation of endometrial polyps affects frozen embryo transfer (FET) outcomes in In Vitro Fertilization (IVF) patients. Researchers reviewed 135 first FET cycles, comparing women who underwent hysteroscopic polypectomy using morcellation (25 patients) with women who did not have polyps (110 patients). The study found no significant differences in implantation rate, clinical pregnancy rate, miscarriage rate, or live birth rate between the two groups. The authors concluded that hysteroscopic morcellation of endometrial polyps does not negatively impact fertility outcomes after FET.



Franchini M, Zolfanelli F, Gallorini M, Giarrè G, Fimiani R, Florio P. Hysteroscopic polypectomy in an office setting: Specimen quality assessment for histopathological evaluation. Eur J Obstet Gynecol Reprod Biol. 2015 Jun;189:64–67.


A retrospective review of consecutive polyp histopathological slides and respective reports from November 2012 to March 2013 was conducted. It included all hysteroscopic tissue removal procedures using either mechanical instruments, a bipolar electrode or the TruClear™ system. Of the 90 reviewed polyp slides, it was shown that the hysteroscopic tissue removal of endometrial polyps in an office setting using the TruClear™ system provides adequate tissue for histological diagnosis, despite the effects of tissue fragmentation.



Ceci O, Franchini M, Cardinale S, Cannone R, Giarrè G, Fascilla FD, Bettocchi S, et.al. Comparison of endometrial polyp recurrence in fertile women after office hysteroscopic endometrial polypectomy using two widely spread techniques. J Obstet Gynaecol Res. 2020 Oct;46(10):2084–2091.


This study compared recurrence rates of endometrial polyps after office hysteroscopic removal using two techniques: bipolar electrode (BE) and hysteroscopic tissue removal systems (HTRs). In 90 women followed for one year, recurrence rates were low and not significantly different between methods (10.4% for BE versus 7.1% for HTRs). However, HTRs resulted in shorter procedure times and less patient discomfort. Overall, both techniques were equally effective in polyp removal, but HTRs offered advantages in efficiency and patient comfort.



Ceci O, Franchini M, Cannone R, Giarrè G, Bettocchi S, Fascilla FD, et.al. Office treatment of large endometrial polyps using TruClear™ 5C: Feasibility and acceptability. J Obstet Gynaecol Res. 2019 Mar;45(3):626–633.


This study evaluated the feasibility and patient acceptability of using the TruClear™ 5C hysteroscopic tissue removal system to treat endometrial polyps, including large polyps (≥20 mm), in an office setting. Results showed high success rates for complete removal (over 96% in both small and large polyps), and minimal pain. The technique was effective, and well tolerated, demonstrating that even large polyps can be successfully treated outside the operating room.