CompletedNot Applicable

Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

United States60 participantsStarted 2016-05

Plain-language summary

The purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the bags throughout and after insufflation and power morcellation. The hypothesis is the bags will remain in tact without leakage from the bags during and after power morcellation using the described contained system, confirming the safety and efficacy of the systems.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * adult premenopausal women (equal or greater than 18 years old) * no symptoms of menopause * undergoing robotic or laparoscopic total or supracervical hysterectomies or myomectomies for the indication of symptomatic uterine fibroids * not candidates for specimen removal via mini-laparotomy incision (as deemed by the study surgeon) or who have refused mini-laparotomy * endometrial biopsy with no suspicion for malignancy Exclusion Criteria: * known or suspected malignancy * peri- or post-menopausal women * specimen that can be removed without power morcellation (e.g., vaginally or through laparoscopic trocars) * adults unable to consent.

What they're measuring

Number of Participants With Egg Albumin Leakage.

Timeframe: Day 0 through the end of morcellation, approximately 30 minutes.

Trial details

NCT IDNCT02777203

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-30

Results submitted2021-07-19

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