A Study to Establish an Eclipse Continence System Registry
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-003705
Sponsor Protocol Number: CA007
About this study
The purpose of this study is to to evaluate the safety and effectiveness of the Eclipse System for the treatment of Fecal Incontinence (FI) in adult women.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult female, age 18 years or older.
- Diagnosis of Fecal Incontinence.
- Clinician recommendation of the Eclipse System.
- Subject provides informed consent and HIPAA authorization.
Exclusion Criteria:
- Females under 18 years of age.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Paul Pettit, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available