Pursuit: Real World Use of the Eclipse System

Last updated: March 9, 2021
Sponsor: Pelvalon, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fecal Incontinence

Rectal Disorders

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT03940573
CA007
  • Ages > 19
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 150
Study Start date:
April 19, 2019
Estimated Completion Date:
December 31, 2021

Study Description

Up to 150 subjects enrolled, in up to 25 sites. Population of all adult female patients with Fecal Incontinence (FI) who present at, or are identified at, participating sites are eligible. This includes patients who are newly prescribed Eclipse, and those already using Eclipse who return for an annual renewal visit during the enrollment period.

Includes fitting of the patient for the Eclipse System with collection of relevant health history data. Patients are provided a temporary device for a trial usage period. Multiple device sizes may be attempted to find the correct fit for the patient, at which point the patient is provided with the long term use Eclipse Insert and enters the treatment period.

During the fitting and treatment period, patient experience will be assessed by surveys, St. Mark's (Vaizey) scores, and the validated global PGI-I index (Patient Global Impression of Improvement). Surveys will be perform at the fitting follow up and at 12 months of device usage, and optionally at 3, 6, and 9 months of device usage.

Connect with a study center

  • The American Association of Female Pelvic Medicine

    Agoura Hills, California 91301
    United States

    Active - Recruiting

  • The Ob-Gyn and Incontinence Center

    Arcadia, California 91006
    United States

    Active - Recruiting

  • Long Beach Urogynecology

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Florida Urogynecology, LLC

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Princeton Urogynecology

    Princeton, New Jersey 08540
    United States

    Active - Recruiting

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