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

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ClinicalTrials.gov Identifier: NCT03940573
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pelvalon, Inc.

Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE April 19, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Fit Rate [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
    Proportion of patients successfully fit
  • Device Size Distribution [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
    Size distribution of devices among successfully fit patients
  • St. Mark's Score (Vaizey) [ Time Frame: 12 months ]
    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
  • PGI-I Score [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Fit Rate [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
    Proportion of patients successfully fit
  • Device Size Distribution [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
    Size distribution of devices among successfully fit patients
  • St. Mark's Score [ Time Frame: 12 months ]
    Change from baseline in mean scores
  • PGI-I Score [ Time Frame: 12 months ]
    Patient global impression of improvement score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • St. Mark's Score (Vaizey) [ Time Frame: 3 months ]
    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
  • St. Mark's Score (Vaizey) [ Time Frame: 6 months ]
    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
  • St. Mark's Score (Vaizey) [ Time Frame: 9 months ]
    Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
  • PGI-I Score [ Time Frame: 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)
  • PGI-I Score [ Time Frame: 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
  • PGI-I Score [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • St. Mark's Score [ Time Frame: 3 months ]
    Change from baseline in mean scores
  • St. Mark's Score [ Time Frame: 6 months ]
    Change from baseline in mean scores
  • St. Mark's Score [ Time Frame: 9 months ]
    Change from baseline in mean scores
  • PGI-I Score [ Time Frame: 3 months ]
    Patient global impression of improvement score
  • PGI-I Score [ Time Frame: 6 months ]
    Patient global impression of improvement score
  • PGI-I Score [ Time Frame: 9 months ]
    Patient global impression of improvement score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pursuit: Real World Use of the Eclipse System
Official Title  ICMJE A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fecal Incontinence
Intervention  ICMJE Device: Eclipse Insert
Rectal Control System.
Study Arms  ICMJE Experimental: Treatment
All patients fitted with the device.
Intervention: Device: Eclipse Insert
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Steve Herbowy 6507966294 Steve@pelvalon.com
Contact: Jared Goor, PhD 8582203876 jared@pelvalon.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940573
Other Study ID Numbers  ICMJE CA007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pelvalon, Inc.
Study Sponsor  ICMJE Pelvalon, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Pettit, MD Mayo Clinic
PRS Account Pelvalon, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP