CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
EcoSac 400 ECO-Tdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02777203
NCT02777203N/ACompleted
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Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

Wake Forest University Health Sciences·interventional·Posted May 19, 2016·Updated Oct 24, 2024

In Brief

A clinical study evaluating EcoSac 400 ECO-T for Leiomyoma. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeiomyoma
CountriesUnited States
CollaboratorsEspiner Medical LTD

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 19, 2016
Enrollment StartMay 1, 2016
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.1 years ago

Interventions

EcoSac 400 ECO-Tdevice

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.