LIBERATE - PRO: Eclipse™ System Registry

NCT03028636 | Completed Results

• 1 other identifier: CA006
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel control.

Conditions

Fecal Incontinence; Bowel Dysfunction; Bowel Incontinence; Accidental Bowel Leakage

Keywords

fecal incontinence; bowel control; accidental bowel leakage; medical device; women's health; vaginal insert; pessary; incontinence; bowel continence; pump

Outcome Measures

Primary Outcomes (1)

• The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score

  The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months.

  3, 6, 9, and 12 months

Secondary Outcomes (1)

• Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score

  3, 6, 9, and 12 months

Other Outcomes (1)

• The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score

  12 months

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects exiting the LIBERATE study who are continuing to use the Eclipse System. Since all of the women in the prior LIBERATE study had to be over the age of 19 to participate in it, this means that all subjects in the registry will be over the age of 19 by default. For information about the LIBERATE study including inclusion/exclusion criteria please see NCT02428595.

You may qualify if:

• Subject has completed the 12-month visit in the LIBERATE study (NCT02428595)
• Subject has elected to continue to use the Eclipse System outside of the LIBERATE study
• Subject provides electronic informed consent and HIPAA authorization

Sponsors & Collaborators

• Pelvalon, Inc.: lead

Study Sites (1)

Pelvalon, Inc.

Sunnyvale, California, 94085, United States

Location

Related Links

• LIBERATE Clinical Trials.gov listing
• Pelvalon, Eclipse manufacturer and Study Sponsor, website

MeSH Terms

Conditions

Fecal Incontinence; Intestinal Diseases

Condition Hierarchy (Ancestors)

Rectal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Clinical Management
• Organization: Pelvalon

steve@pelvalon.com

650-276-0130

Study Officials

• Gena Dunivan, MD

  Pelvalon Inc.; University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: January 23, 2017
• Study Start: September 19, 2016
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: January 28, 2020
• Results First Posted: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)