Recruiting

Observational Study

Sponsor:

HealthPartners Institute

Code:

NCT06524401

Conditions

Ostomy

Enterocutaneous Fistula

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Limpet

Control

Study Details

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. Secondary objectives include evaluating dressing leak rates and causes of complications (e.g., edema, tissue oxygen saturation, and poor stoma eversion). The main questions it aims to answer are:

Primary Hypothesis 1: Peristomal Skin Complications will decrease

Primary Hypothesis 2: Dressing Leak Rates will decrease

Participants will:

  • Receive either the Limpet device or standard of care adhesive ostomy pouch dressing
  • Return every 7 days for study visits for 30 days to receive device replacement, wound imaging, blood tests, and quality of life surveys.

Conditions

Ostomy

Enterocutaneous Fistula

Study ID

NCT06524401

Start date

Nov 18, 2024

Status verified date

Sep, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Limpet

Participants in this arm will utilize the subject device as intended to be used.

active comparator: Control

Standard treatment with standard of care adhesive ostomy pouches.

Interventions

Limpet

Limpet participants will have their device placed by a clinician. Upon discharge, a portable vacuum pump will be issued to provide negative pressure (e.g., 3M Prevena or Snap; ConvaTec Avelle; or Pensar MicroDoc). These systems are compact, fit in a pocket, are simple to operate, and commonly used in the outpatient setting to provide multiple weeks of therapy. Participants will be furnished with materials to address potential dressing problems while at home: extra waste pouches, adhesive drape strips for sealing air leaks, and standard of care adhesive ostomy pouches and accessories as a backup plan in the event of a Limpet failure.

Control

Control participants will receive standard of care adhesive ostomy pouch dressings. Participants will be furnished with materials to address potential dressing problems while at home: adhesive ostomy pouches and accessories for pouch replacement. The Control group will change their pouches at home 2 to 5 times per week or more frequently if needed, as per the current standard of care.

Primary outcome measure

  • Peristomal Skin Complications (PSCs) [ Time Frame: 30 days ]
  • Dressing Leak Rates [ Time Frame: 30 Days ]

Central Contacts and Locations

Central contacts

Allison Kehren

651-254-5342Allison.J.Kehren@HealthPartners.Com

Locations

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Allison Kehren

651-254-5342Allison.J.Kehren@HealthPartners.Com

More Information

Sponsor

HealthPartners Institute

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Keywords

  • Stoma
  • Ileostomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HealthPartners Institute on 2025-09-25.