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NCT06524401 · ClinicalTrials.gov registry record · NA
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
A NA study of Ostomy and Enterocutaneous Fistula, sponsored by HealthPartners Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT06524401: Recruiting NA study of Ostomy and Enterocutaneous Fistula, sponsored by HealthPartners Institute.
NCT06524401 is a NA study of Ostomy and Enterocutaneous Fistula that is actively recruiting participants, run by HealthPartners Institute. The registered enrollment target is 92 participants, below the 885-participant average among 6 other Ostomy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06524401, a NA study of Ostomy and Enterocutaneous Fistula, is actively recruiting participants, sponsored by HealthPartners Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
We hypothesize that the Limpet will demonstrate a significant improvement in PSCs compared to standard of care adhesive ostomy pouches. Specifically, we anticipate a raw difference of 35% in PSCs for the pooled cohorts, with a complication rate of 50% in the control group and 15% in the Limpet group.
Conditions Studied
Interventions
- DEVICE Control
- DEVICE Limpet
Study Locations (1)
Minnesota
- Regions Hospital - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2024-11-18 |
| Est. Completion | 2029-03 |
| Phase | NA |
What NCT06524401 shows while recruiting
NCT06524401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 885-participant average among 6 other Ostomy trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Ostomy appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT06524401 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06524401 about?
NCT06524401 is a clinical study titled "Novel Post-Surgical Incision Management to Prevent Ostomy Complications". 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, ...
What is the current status of trial NCT06524401?
This trial is currently recruiting. It is a NA study. The enrollment target is 92 participants. The study started on 2024-11-18. Estimated completion is 2029-03.
What conditions does trial NCT06524401 study?
This clinical trial studies the following conditions: Ostomy, Enterocutaneous Fistula.
What interventions are being tested in trial NCT06524401?
The interventions under investigation include: Control (DEVICE), Limpet (DEVICE).
Who is sponsoring clinical trial NCT06524401?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06524401 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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