Pursuit: Real World Use of the Eclipse System
NCT03940573 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2021-03-11
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.
Conditions
- Fecal Incontinence
Interventions
- DEVICE
-
Eclipse Insert
Rectal Control System.
Sponsors & Collaborators
-
Pelvalon, Inc.
lead INDUSTRY
Principal Investigators
-
Paul Pettit, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-19
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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