Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 10, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedResults Posted
Study results publicly available
October 8, 2024
CompletedOctober 24, 2024
October 1, 2024
3.2 years
May 10, 2016
July 19, 2021
October 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Egg Albumin Leakage.
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."
Day 0 through the end of morcellation, approximately 30 minutes.
Secondary Outcomes (1)
Morcellation Time
Day 0 through the end of morcellation, approximately 30 minutes.
Study Arms (1)
EcoSac 46 400 ECO-T morcellation bag cohort
OTHERProspective 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.
Interventions
Laparoscopy will be performed in the standard multi-port technique. The specimen will be morcellated in the EcoSac400 ECO-T bag. This study is a pilot study with one arm (all patients will use the new EcoSac400 ECO-T bag.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- Espiner Medical LTDcollaborator
Study Sites (1)
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Related Publications (5)
Cholkeri-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: 25460317BACKGROUNDCohen 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: 25162248BACKGROUNDEinarsson 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: 24769447BACKGROUNDKho 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: 25198260BACKGROUNDVargas 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: 25452122BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary Johnston
- Organization
- The Advanced Gyn Surgery Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Miller, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2016
First Posted
May 19, 2016
Study Start
May 1, 2016
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
October 24, 2024
Results First Posted
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share