Pursuit: Real World Use of the Eclipse System (PURSUIT)

Pelvalon

Status: Unknown

Conditions: Fecal Incontinence

Treatments: Device: Eclipse Insert

Study type: Interventional

Funder types: Industry

Identifiers

NCT03940573

CA007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Treatment

Experimental group

Description:

All patients fitted with the device.

Treatment:

Device: Eclipse Insert