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NCT02428595 · ClinicalTrials.gov registry record · NA

A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

A NA study of Fecal Incontinence, sponsored by Pelvalon.

Completed
Registry status
NA
Development phase
137
Enrollment target
11
Study locations

NCT02428595 is a NA study of Fecal Incontinence that has completed, run by Pelvalon. The registered enrollment target is 137 participants, below the 329-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (58% lower). The trial reports 11 study locations across 11 states.

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The verdict

NCT02428595, a NA study of Fecal Incontinence, has completed, sponsored by Pelvalon.

COMPLETED
Registry status
NA
Development phase
137 participants
Enrollment target
11
Study locations

Study 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.

Conditions Studied

Fecal Incontinence

Interventions

  • DEVICE Eclipse™ System

Study Locations (11)

Alabama

  • University of Alabama - Birmingham

Massachusetts

  • Massachusetts General Hospital (MGH) - Boston

New Mexico

  • University of New Mexico - Albuquerque

North Carolina

  • University of North Carolina - Raleigh

Ohio

  • Christ Hospital - Cincinnati

Oklahoma

  • University of Oklahoma - Oklahoma City

Pennsylvania

  • University of Pennsylvania - Philadelphia

Rhode Island

  • Brown University (WIHRI) - Providence

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2015-05-15
Est. Completion 2018-07-18
Phase NA

Sponsor

Pelvalon

3 total trials

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What the Registry Record Tells You About NCT02428595

The ClinicalTrials.gov registry entry for NCT02428595 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 329-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (58% lower). The listed sponsor is Pelvalon, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Eclipse™ System is the first listed.

NCT02428595 reports 11 study locations spanning 11 distinct geographic areas - top geographies include Alabama, Massachusetts, New Mexico.

Frequently Asked Questions

What is clinical trial NCT02428595 about?

NCT02428595 is a clinical study titled "A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women". 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.

What is the current status of trial NCT02428595?

This trial is currently completed. It is a NA study. The enrollment target is 137 participants. The study started on 2015-05-15. Estimated completion is 2018-07-18.

What conditions does trial NCT02428595 study?

This clinical trial studies the following conditions: Fecal Incontinence.

What interventions are being tested in trial NCT02428595?

The interventions under investigation include: Eclipse™ System (DEVICE).

Who is sponsoring clinical trial NCT02428595?

This trial is sponsored by Pelvalon, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02428595 being conducted?

This trial has 11 study locations across Alabama, Massachusetts, New Mexico, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.