Recruiting

Eclipse System

Sponsor:

Pelvalon, Inc.

Code:

NCT03940573

Conditions

Fecal Incontinence

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Eclipse Insert

Study Details

Brief summary:

A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.

Conditions

Fecal Incontinence

Study ID

NCT03940573

Start date

Apr 19, 2019

Status verified date

Mar, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult female
2. Diagnosis of Fecal Incontinence
3. Clinician recommendation of the Eclipse System
4. Subject provides informed consent and HIPAA authorization

No Exclusion Criteria.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

All patients fitted with the device.

Interventions

Eclipse Insert

Rectal Control System.

Primary outcome measure

  • Fit Rate [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
  • Device Size Distribution [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
  • St. Mark's Score (Vaizey) [ Time Frame: 12 months ]
  • PGI-I Score [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Steve Herbowy

6507966294Steve@pelvalon.com

Jared Goor, PhD

8582203876jared@pelvalon.com

Locations

The American Association of Female Pelvic Medicine

Recruiting

Agoura Hills, California, United States, 91301

Contacts

Shirley Louis

818-991-0988

Principal Investigator:

Sherry Thomas, MD

The Ob-Gyn and Incontinence Center

Recruiting

Arcadia, California, United States, 91006

Principal Investigator:

Prema Kothandaraman, MD

Long Beach Urogynecology

Recruiting

Long Beach, California, United States, 90806

Contacts

Dara France

562-426-4904

Principal Investigator:

Jocelyn Craig, MD

Florida Urogynecology, LLC

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Darlene Jones

904-652-0373

Principal Investigator:

Jason Thompson, MD

Princeton Urogynecology

Recruiting

Princeton, New Jersey, United States, 08540

Contacts

Alison Shaltis

609-924-2230

Principal Investigator:

Heather van Raalte, MD

More Information

Sponsor

Pelvalon, Inc.

Last update posted

Mar 11, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pelvalon, Inc. on 2021-03-11.