New limpet device aims to stop ostomy leaks and skin woes
NCT ID NCT06524401
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called Limpet, which uses gentle suction to keep the area around an ostomy clean and dry. About 92 adults who have had ileostomy surgery or have a high-output fistula will either get the Limpet or standard adhesive pouches. Researchers will check for skin problems and leaks over 30 days to see if the Limpet works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Limpet device (negative pressure wound therapy system)
- What this could lead to
- If it works, this could give people with ostomies a more reliable, less leaky way to manage their surgical opening, reducing skin irritation and hospital visits.
- What could go wrong
- This is a small, early-stage trial with only 92 participants, so results may not apply to everyone. The device may not be more effective than standard care, and some people may find it uncomfortable or difficult to use at home.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 92 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Regions Hospital
RECRUITINGSaint Paul, Minnesota, 55101, United States
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- Thousands with ostomies to share Real-World data in new registry
- New study aims to reduce skin problems for ostomy patients