Clinical trial NCT03940573: Pursuit: Real World Use of the Eclipse System
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
Overall status: UNKNOWN
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Pelvalon, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Fit Rate
timeFrame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
measure: Device Size Distribution
timeFrame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
measure: St. Mark's Score (Vaizey)
timeFrame: 12 months
measure: PGI-I Score
timeFrame: 12 months
Secondary outcomes:
measure: St. Mark's Score (Vaizey)
timeFrame: 3 months
measure: St. Mark's Score (Vaizey)
timeFrame: 6 months
measure: St. Mark's Score (Vaizey)
timeFrame: 9 months
measure: PGI-I Score
timeFrame: 3 months
measure: PGI-I Score
timeFrame: 6 months
measure: PGI-I Score
timeFrame: 9 months
Other outcomes:
Locations:
city: Agoura Hills
country: United States
facility: The American Association of Female Pelvic Medicine
state: California
city: Arcadia
country: United States
facility: The Ob-Gyn and Incontinence Center
state: California
city: Long Beach
country: United States
facility: Long Beach Urogynecology
state: California
city: Jacksonville
country: United States
facility: Florida Urogynecology, LLC
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Princeton
country: United States
facility: Princeton Urogynecology
state: New Jersey
Study officials:
affiliation: Mayo Clinic
name: Paul Pettit, MD
role: PRINCIPAL_INVESTIGATOR
References: