N/A
N=60
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
Leiomyoma
Bottom Line
View on ClinicalTrials.gov: NCT02777203 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Egg Albumin Leakage. — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EcoSac 400 ECO-T (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Egg Albumin Leakage. |
— | — |
| SECONDARY Morcellation Time |
26.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02777203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.