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Trial record 5 of 5 for:    Sherry Thomas

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940573
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Pelvalon, Inc.

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
Fecal Incontinence Device: Eclipse Insert Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 19, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




Primary Outcome Measures :
  1. Fit Rate [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
    Proportion of patients successfully fit

  2. 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

  3. 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)

  4. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940573


Contacts
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Contact: Steve Herbowy 6507966294 Steve@pelvalon.com
Contact: Jared Goor, PhD 8582203876 jared@pelvalon.com

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

Documents provided by Pelvalon, Inc.:
Study Protocol  [PDF] March 1, 2019

Additional Information:
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Responsible Party: Pelvalon, Inc.
ClinicalTrials.gov Identifier: NCT03940573    
Other Study ID Numbers: CA007
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases