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

Primary Purpose

Fecal Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eclipse Insert
Sponsored by
Pelvalon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The American Association of Female Pelvic MedicineRecruiting
  • The Ob-Gyn and Incontinence CenterRecruiting
  • Long Beach UrogynecologyRecruiting
  • Florida Urogynecology, LLCRecruiting
  • Mayo Clinic Jacksonville
  • Princeton UrogynecologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

All patients fitted with the device.

Outcomes

Primary Outcome Measures

Fit Rate
Proportion of patients successfully fit
Device Size Distribution
Size distribution of devices among successfully fit patients
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
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)

Secondary Outcome Measures

St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
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)
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
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)

Full Information

First Posted
May 2, 2019
Last Updated
March 9, 2021
Sponsor
Pelvalon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03940573
Brief Title
Pursuit: Real World Use of the Eclipse System
Acronym
PURSUIT
Official Title
A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pelvalon, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
All patients fitted with the device.
Intervention Type
Device
Intervention Name(s)
Eclipse Insert
Intervention Description
Rectal Control System.
Primary Outcome Measure Information:
Title
Fit Rate
Description
Proportion of patients successfully fit
Time Frame
Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Title
Device Size Distribution
Description
Size distribution of devices among successfully fit patients
Time Frame
Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Title
St. Mark's Score (Vaizey)
Description
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time Frame
12 months
Title
PGI-I Score
Description
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
St. Mark's Score (Vaizey)
Description
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time Frame
3 months
Title
St. Mark's Score (Vaizey)
Description
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time Frame
6 months
Title
St. Mark's Score (Vaizey)
Description
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time Frame
9 months
Title
PGI-I Score
Description
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Time Frame
3 months
Title
PGI-I Score
Description
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
Time Frame
6 months
Title
PGI-I Score
Description
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Time Frame
9 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult female Diagnosis of Fecal Incontinence Clinician recommendation of the Eclipse System Subject provides informed consent and HIPAA authorization No Exclusion Criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Herbowy
Phone
6507966294
Email
Steve@pelvalon.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jared Goor, PhD
Phone
8582203876
Email
jared@pelvalon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Pettit, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The American Association of Female Pelvic Medicine
City
Agoura Hills
State/Province
California
ZIP/Postal Code
91301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Louis
Phone
818-991-0988
First Name & Middle Initial & Last Name & Degree
Sherry Thomas, MD
Facility Name
The Ob-Gyn and Incontinence Center
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kumar Kothandaraman
First Name & Middle Initial & Last Name & Degree
Prema Kothandaraman, MD
Facility Name
Long Beach Urogynecology
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dara France
Phone
562-426-4904
First Name & Middle Initial & Last Name & Degree
Jocelyn Craig, MD
Facility Name
Florida Urogynecology, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darlene Jones
Phone
904-652-0373
First Name & Middle Initial & Last Name & Degree
Jason Thompson, MD
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Pettit, MD
Phone
904-953-2977
Email
paul.pettit@mayo.edu
Facility Name
Princeton Urogynecology
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Shaltis
Phone
609-924-2230
First Name & Middle Initial & Last Name & Degree
Heather van Raalte, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://eclipsesystem.com/
Description
Pelvalon, Eclipse manufacturer and Study Sponsor, website

Learn more about this trial

Pursuit: Real World Use of the Eclipse System

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