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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All patients fitted with the device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eclipse Insert | Device | Rectal Control System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| St. Mark's Score (Vaizey) | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) | 3 months |
| St. Mark's Score (Vaizey) | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) |
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Inclusion Criteria:
No Exclusion Criteria.
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Herbowy | Contact | 6507966294 | Steve@pelvalon.com | |
| Jared Goor, PhD | Contact | 8582203876 | jared@pelvalon.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Pettit, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The American Association of Female Pelvic Medicine | Recruiting | Agoura Hills | California | 91301 | United States |
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| Label | URL |
|---|---|
| Pelvalon, Eclipse manufacturer and Study Sponsor, website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2019 | May 2, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 6 months |
| St. Mark's Score (Vaizey) | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) | 9 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) | 3 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)e | 6 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) | 9 months |
| The Ob-Gyn and Incontinence Center | Recruiting | Arcadia | California | 91006 | United States |
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| Long Beach Urogynecology | Recruiting | Long Beach | California | 90806 | United States |
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| Florida Urogynecology, LLC | Recruiting | Jacksonville | Florida | 32216 | United States |
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| Mayo Clinic Jacksonville | Not yet recruiting | Jacksonville | Florida | 32224 | United States |
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| Princeton Urogynecology | Recruiting | Princeton | New Jersey | 08540 | United States |
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