CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 137 enrolled
Drug / intervention
Eclipse™ Systemdevice
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/NCT02428595
NCT02428595N/ACompleted
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A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

Pelvalon, Inc.·interventional·Posted Apr 29, 2015·Updated Sep 24, 2019

In Brief

A clinical study evaluating Eclipse™ System for Fecal Incontinence. Completed, enrolled 137 participants across 11 sites.

Detailed Summary

Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 29, 2015
Enrollment StartMay 15, 2015
Primary CompletionJul 18, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.2 years ago

Interventions

Eclipse™ Systemdevice

The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System.