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PURSUIT: Pursuit: Real World Use of the Eclipse System

Sponsor
Pelvalon, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03940573
Collaborator
(none)
150
Enrollment
6
Locations
1
Arm
32.4
Anticipated Duration (Months)
25
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Device: Eclipse Insert
 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
Anticipated Enrollment :
150 participants
Allocation:
N/A
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 :
Apr 19, 2019
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 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 [Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening]

    Proportion of patients successfully fit

  2. Device Size Distribution [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) [12 months]

    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)

  4. PGI-I Score [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) [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) [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) [9 months]

    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)

  4. PGI-I Score [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 [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 [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

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 The American Association of Female Pelvic Medicine Agoura Hills California United States 91301
2 The Ob-Gyn and Incontinence Center Arcadia California United States 91006
3 Long Beach Urogynecology Long Beach California United States 90806
4 Florida Urogynecology, LLC Jacksonville Florida United States 32216
5 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
6 Princeton Urogynecology Princeton New Jersey United States 08540

Sponsors and Collaborators

  • Pelvalon, Inc.

Investigators

  • Principal Investigator: Paul Pettit, MD, Mayo Clinic

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pelvalon, Inc.
ClinicalTrials.gov Identifier:
NCT03940573
Other Study ID Numbers:
  • CA007
First Posted:
May 7, 2019
Last Update Posted:
Mar 11, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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.:
No
Additional relevant MeSH terms:
Fecal Incontinence

Study Results

No Results Posted as of Mar 11, 2021