Pursuit: Real World Use of the Eclipse System

Fecal Incontinence Clinical Trial

— PURSUIT  

Official title:

A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940573
• Other study ID #: CA007
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Pelvalon, Inc.
• Contact: Steve Herbowy
• Phone: 6507966294
• Email: Steve[@]pelvalon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Eclipse Insert
Rectal Control System.

Locations

Country	Name	City	State
United States	The American Association of Female Pelvic Medicine	Agoura Hills	California
United States	The Ob-Gyn and Incontinence Center	Arcadia	California
United States	Florida Urogynecology, LLC	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Long Beach Urogynecology	Long Beach	California
United States	Princeton Urogynecology	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pelvalon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fit Rate	Proportion of patients successfully fit	Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Primary	Device Size Distribution	Size distribution of devices among successfully fit patients	Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Primary	St. Mark's Score (Vaizey)	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)	12 months
Primary	PGI-I Score	Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)	12 months
Secondary	St. Mark's Score (Vaizey)	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)	3 months
Secondary	St. Mark's Score (Vaizey)	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)	6 months
Secondary	St. Mark's Score (Vaizey)	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)	9 months
Secondary	PGI-I Score	Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)	3 months
Secondary	PGI-I Score	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 months
Secondary	PGI-I Score	Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)	9 months

External Links

•   Pelvalon, Eclipse manufacturer and Study Sponsor, website