BridgeMD
New treatment option for Ostomy
Official title Novel Post-Surgical Incision Management to Prevent Ostomy Complications
ClinicalTrials.gov ID: NCT06524401
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility 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.
- 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 how well it works or...
The study team makes the final eligibility decision.
Where it's taking place
- Saint Paul, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Paul, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.