Pursuit: Real World Use of the Eclipse System (PURSUIT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Eclipse Insert

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steve Herbowy; Phone Number: 6507966294; Email: Steve@pelvalon.com
• Study Contact Backup: Name: Jared Goor, PhD; Phone Number: 8582203876; Email: jared@pelvalon.com

Study Locations

• United States
  • California
    • Agoura Hills, California, United States, 91301
      • Recruiting
      • The American Association of Female Pelvic Medicine
      • Contact: Shirley Louis; Phone Number: 818-991-0988
    • Arcadia, California, United States, 91006
      • Recruiting
      • The Ob-Gyn and Incontinence Center
      • Contact: Kumar Kothandaraman
      • Principal Investigator: Prema Kothandaraman, MD
    • Long Beach, California, United States, 90806
      • Recruiting
      • Long Beach Urogynecology
      • Contact: Dara France; Phone Number: 562-426-4904
      • Principal Investigator: Jocelyn Craig, MD
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Not yet recruiting
      • Mayo Clinic Jacksonville
      • Contact: Paul Pettit, MD; Phone Number: 904-953-2977; Email: paul.pettit@mayo.edu
    • Jacksonville, Florida, United States, 32216
      • Recruiting
      • Florida Urogynecology, LLC
      • Contact: Darlene Jones; Phone Number: 904-652-0373
      • Principal Investigator: Jason Thompson, MD
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Recruiting
      • Princeton Urogynecology
      • Contact: Alison Shaltis; Phone Number: 609-924-2230
      • Principal Investigator: Heather van Raalte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; All patients fitted with the device.	Device: Eclipse Insert; Rectal Control System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fit Rate	Proportion of patients successfully fit	Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
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
St. Mark's Score (Vaizey)	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)	12 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
St. Mark's Score (Vaizey)	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)	3 months
St. Mark's Score (Vaizey)	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)	6 months
St. Mark's Score (Vaizey)	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)	9 months
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
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
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

Collaborators and Investigators

• Sponsor: Pelvalon, Inc.
• Investigators: Principal Investigator: Paul Pettit, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Pelvalon, Eclipse manufacturer and Study Sponsor, website

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: CA007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: No