About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Pursuit: Real World Use of the Eclipse System

Clinicaltrials.gov identifier NCT03940573

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted January 18, 2020

Study Description

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.

  • Condition or Disease:Fecal Incontinence
  • Intervention/Treatment: Device: Eclipse Insert
  • Phase: N/A
Detailed 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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Treatment
All patients fitted with the device.
Device: Eclipse Insert
Rectal Control System.
Outcome Measures
  • Primary Outcome Measures: 1. Fit Rate [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
    Proportion of patients successfully fit
  • 2. Device Size Distribution [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
    Size distribution of devices among successfully fit patients
  • 3. St. Mark's Score (Vaizey) [ Time Frame: 12 months ]
    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
  • 4. PGI-I Score [ Time Frame: 12 months ]
    Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
  • Secondary Outcome Measures: 1. St. Mark's Score (Vaizey) [ Time Frame: 3 months ]
    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
  • 2. St. Mark's Score (Vaizey) [ Time Frame: 6 months ]
    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
  • 3. St. Mark's Score (Vaizey) [ Time Frame: 9 months ]
    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
  • 4. PGI-I Score [ Time Frame: 3 months ]
    Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
  • 5. PGI-I Score [ Time Frame: 6 months ]
    Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)e
  • 6. PGI-I Score [ Time Frame: 9 months ]
    Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Eligibility Criteria
  • Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Steve Herbowy 6507966294 Steve@pelvalon.com

Contact: Jared Goor, PhD 8582203876 jared@pelvalon.com

Locations

United States, California
The American Association of Female Pelvic Medicine
Agoura Hills

United States, California
The Ob-Gyn and Incontinence Center
Arcadia

United States, California
Long Beach Urogynecology
Long Beach

United States, Florida
Florida Urogynecology, LLC
Jacksonville

United States, Florida
Mayo Clinic Jacksonville
Jacksonville

United States, New Jersey
Princeton Urogynecology
Princeton

Sponsors and Collaborators

Pelvalon, Inc.

Investigators

Principal Investigator: Paul Pettit, MD Mayo Clinic

More Information
  • Responsible Party: Pelvalon, Inc.
  • ClinicalTrials.gov Identifier: NCT03940573 History of Changes
  • Other Study ID Numbers: CA007
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: January 18, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Fecal Incontinence