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
1 other identifier
interventional
150
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2019
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2019
CompletedFirst Submitted
Initial submission to the registry
May 2, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 11, 2021
March 1, 2021
2.7 years
May 2, 2019
March 9, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
St. Mark's Score (Vaizey)
3 months
St. Mark's Score (Vaizey)
6 months
St. Mark's Score (Vaizey)
9 months
PGI-I Score
3 months
PGI-I Score
6 months
- +1 more secondary outcomes
Study Arms (1)
Treatment
EXPERIMENTALAll patients fitted with the device.
Interventions
Eligibility Criteria
You may qualify if:
- Adult female
- Diagnosis of Fecal Incontinence
- Clinician recommendation of the Eclipse System
- Subject provides informed consent and HIPAA authorization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pelvalon, Inc.lead
Study Sites (6)
The American Association of Female Pelvic Medicine
Agoura Hills, California, 91301, United States
The Ob-Gyn and Incontinence Center
Arcadia, California, 91006, United States
Long Beach Urogynecology
Long Beach, California, 90806, United States
Florida Urogynecology, LLC
Jacksonville, Florida, 32216, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Princeton Urogynecology
Princeton, New Jersey, 08540, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Pettit, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2019
First Posted
May 7, 2019
Study Start
April 19, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
March 11, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share