Clinical trial · Interventional
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
NCT02777203CI-TRIAL-00081889completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EcoSac 400 ECO-T | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- EcoSac 46 400 ECO-T morcellation bag cohort
- description
- Prospective study of one cohort of subjects undergoing power morcellation within the EcoSac 46 400 ECO-T morcellation bag after a laparoscopic or robotic-assisted hysterectomy or myomectomy.
- interventionNames
- Device: EcoSac 400 ECO-T
Primary outcomes (1)
- measure
- Number of Participants With Egg Albumin Leakage.
- timeFrame
- Day 0 through the end of morcellation, approximately 30 minutes.
- description
- After morcellation is complete, the bag was removed from the abdomen and taken out of the operating room to the frozen section room to inspect the integrity of the bag. Five hundred milliliters of egg albumin combined with 0.5 milliliters of methylene blue were placed into the bag to assess for any leakage.Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDCholkeri-Singh A, Miller CE. Power morcellation in a specimen bag. J Minim Invasive Gynecol. 2015 Feb;22(2):160. doi: 10.1016/j.jmig.2014.10.012. Epub 2014 Oct 18. PMID 25460317
- BACKGROUNDCohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421. PMID 25162248
- BACKGROUNDEinarsson JI, Cohen SL, Fuchs N, Wang KC. In-bag morcellation. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):951-3. doi: 10.1016/j.jmig.2014.04.010. Epub 2014 Apr 25. PMID 24769447
- BACKGROUNDKho KA, Anderson TL, Nezhat CH. Intracorporeal electromechanical tissue morcellation: a critical review and recommendations for clinical practice. Obstet Gynecol. 2014 Oct;124(4):787-793. doi: 10.1097/AOG.0000000000000448. PMID 25198260
- BACKGROUNDVargas MV, Cohen SL, Fuchs-Weizman N, Wang KC, Manoucheri E, Vitonis AF, Einarsson JI. Open power morcellation versus contained power morcellation within an insufflated isolation bag: comparison of perioperative outcomes. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):433-8. doi: 10.1016/j.jmig.2014.11.010. Epub 2014 Nov 29. PMID 25452122