New device for managing post-surgical ostomy complications
Official title: Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Run by HealthPartners Institute · NCT06524401 · Data updated 2026-11-12
This study is testing a new device called the Limpet to see if it can help people with ostomies and fistulas have fewer skin problems and leaks compared to regular ostomy pouches.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | HealthPartners Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Saint Paul, Minnesota) |
| Status | Recruiting |
| Started | November 18, 2024 |
| Main results expected | January 2029 |
| Study ends | March 2029 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT06524401 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 undergoing ileostomy surgery or with high-output enterocutaneous fistulas.
✕Probably not a fit
Patients with a life expectancy of less than 30 days or those with specific types of fistulas may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and effectiveness of the Limpet device compared to standard ostomy pouches in reducing complications for patients with ostomies and enterocutaneous fistulas. Participants will receive either the Limpet or standard care dressing and will return weekly for 30 days for device replacement, wound imaging, blood tests, and quality of life assessments. The study aims to demonstrate a significant reduction in peristomal skin complications and dressing leak rates. It focuses on patients undergoing ileostomy surgery or those with high-output enterocutaneous fistulas.
Why it matters
Potential benefit: If successful, this study could significantly reduce complications and improve the quality of life for patients with ostomies and fistulas.
How similar studies have gone: Other studies have shown promise in similar approaches, but this specific device's effectiveness is being evaluated for the first time.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Regions Hospital
Saint Paul, Minnesota, United States Recruiting
Study contacts
- Study coordinator: Allison Kehren
- Email: Allison.J.Kehren@HealthPartners.Com
- Phone: 651-254-5342
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Telephone follow-up by a WOC nurse after ostomy surgery
We’re testing whether a WOC nurse’s phone check-in after ostomy surgery can reduce hospital readmissions for adults with a new ostomy.
-
Two Ostomy Seals/Rings after surgery
This study tests two ostomy seals/rings in adults who recently had ostomy surgery in the UK to see if they fit better and protect the skin.
-
Using a 3D model to educate patients before urologic bowel surgeries
This study is testing if using a 3D model to teach patients about urologic bowel surgeries can help them understand their care better and improve their overall experience.
-
Personalized 3D Printed Ostomy Appliance
This study is testing if a custom 3D printed ostomy appliance can help people with ostomies feel more comfortable and satisfied compared to their regular appliance.
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Training to improve quality of life for individuals with a stoma
This study tests whether a special training program can help people with a stoma feel better and become more independent in managing their care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.