Cutaneous Fistula Clinical Trial
Official title:
Pouching of Fistula - a Non-comparative, Multi-center Investigation
Verified date | January 2012 |
Source | Coloplast A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.
Status | Completed |
Enrollment | 22 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years or older - Capable of giving informed consent - Have to be hospitalized - Have a fistula with the opening on the skin in the abdominal area Exclusion Criteria: - Pregnant and/or breast-feeding - Receiving radiation- or chemotherapy during the investigation period |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Morton Plant Hospital | Clearwarter | Florida |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Presbyterian Hospital of Dallas | Dallas | Texas |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | St. Francis Hospital and Medical Center | Hartford | Connecticut |
United States | University of Minnesota Medical Center Fairview | Minneapolis | Minnesota |
United States | University of Minnesota Medical Center Fairview - Riverside | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nurse's preference to use the test product in the future | Up to 18 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02870556 -
Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula
|
N/A |