Status:
RECRUITING
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Lead Sponsor:
HealthPartners Institute
Conditions:
Ostomy
Enterocutaneous Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients. Se...
Detailed Description
The Limpet is a single-use device intended for effluent management and promotion of healing of intact and injured skin surrounding enterocutaneous fistulae and ostomies. Our study focuses on small bo...
Eligibility Criteria
Inclusion
- Participant is greater than 18 years of age, inclusive
- Participant is undergoing ileostomy surgery or,
- has an enterocutaneous fistula with output over 500cc in 24 hours
- Participants stoma will have a maximum diameter of 1.5 inches based on measurements from the Investigator or Sponsor.
- Area around the stoma must have no injury through the dermis (i.e., intact skin)
- Participant is willing and able to comply with all protocol-specified requirements
- Participant is capable of reading and understanding English and will provide written informed consent to participate.
Exclusion
- Unable/unwilling to attend the follow-up appointments
- Participant has a life expectancy \< 30 days.
- Participant has a stature too small for use of the Limpet in the opinion of the Investigator or Sponsor.
- Participant has an enteroatmospheric fistula (enteric fistula to an open wound)
- Participant is scheduling/planning concurrent chemotherapy or other radiation treatment during the study follow-up period
- Participant has a history of sensitivity or allergy to hydrocolloids or other materials in the Limpet device.
- Participant is pregnant or planning to become pregnant (verbal report).
- Participant is unable or unwilling to provide informed consent.
- Participant is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
- Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06524401
Start Date
November 18 2024
End Date
March 1 2029
Last Update
September 25 2025
Active Locations (1)
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1
Regions Hospital
Saint Paul, Minnesota, United States, 55101