Fecal Incontinence
Conditions
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.
Interventions
DEVICEEclipse Insert
Rectal Control System.
Sponsors
Pelvalon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fit Rate | Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening | Proportion of patients successfully fit |
| Device Size Distribution | 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) | 12 months | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) |
| PGI-I Score | 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
| Measure | Time frame | Description |
|---|---|---|
| St. Mark's Score (Vaizey) | 3 months | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) |
| PGI-I Score | 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) |
Countries
United States
Contacts
Primary ContactSteve Herbowy
Backup ContactJared Goor, PhD
Outcome results
None listed