Pursuit: Real World Use of the Eclipse System

NCT03940573 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-03-11

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940573 on ClinicalTrials.gov