Limpet Device for Ostomy Complications

Overseen By Allison Kehren

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Nicotine use, Chemotherapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new device called the Limpet can reduce complications for people with ostomies or fistulas. The researchers aim to determine if the Limpet decreases skin problems and leaks compared to regular ostomy pouches. Participants will either use the Limpet or continue with the usual pouch, visiting the study center weekly for a month. Ideal candidates are those scheduled for ileostomy surgery or those with a high-output fistula, provided their skin around the stoma is healthy and intact. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future ostomy care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are scheduling or planning concurrent chemotherapy or radiation treatment, you may not be eligible to participate.

What prior data suggests that the Limpet device is safe for ostomy and fistula patients?

Research has shown that the Limpet device, currently under testing for individuals with ostomies and fistulas, may help reduce complications. Early results suggest it can lessen common issues like skin problems around the stoma (the opening on the abdomen). The device aims to improve quality of life by reducing skin issues and leaks from the dressing.

Although the Limpet device remains in testing, the FDA has recognized it as a "Breakthrough Device," indicating its potential to offer better treatment for serious or life-changing conditions. However, since the trial phase does not focus on safety in humans, information on side effects or tolerance remains limited. If the device performs well in this trial, it could become an important tool for managing ostomy-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Limpet device for ostomy complications because it offers a new approach to managing these issues. Unlike the standard adhesive ostomy pouches, which can sometimes cause skin irritation and leaks, the Limpet device is designed for enhanced adhesion and comfort. This device aims to improve the quality of life for ostomy patients by reducing complications associated with traditional pouches, offering a potentially more reliable and comfortable solution.

What evidence suggests that the Limpet device is effective for reducing ostomy complications?

Research has shown that the Limpet device, which participants in this trial may receive, might help reduce complications for people with ostomies and fistulas. Early results are promising, indicating that the device can lessen issues like skin problems and leaks from dressings. Studies reveal that up to 70% of ostomy patients experience complications, often leading to costly hospital visits. The Limpet is designed to address these issues by providing a better fit and more protection than standard pouches. Initial findings suggest that using the Limpet could result in fewer skin problems and less leakage, enhancing users' quality of life. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having ileostomy surgery or have an enterocutaneous fistula with significant output. Their stoma should be no larger than 1.5 inches, and the skin around it must be intact. Participants need to follow the study's procedures and understand English, Spanish, Hmong, or Somali.

Inclusion Criteria

I have a fistula on my skin with a discharge of more than 500cc in 24 hours.

I am over 18 years old.

I am scheduled for ileostomy surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Baseline

Baseline appointment clinic visit and randomization into treatment groups

1 day

1 visit (in-person)

Treatment

Participants receive either the Limpet device or standard of care adhesive ostomy pouch dressing with weekly clinic visits for device replacement, wound imaging, blood tests, and quality of life surveys

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Limpet

Trial Overview The Limpet device is being tested against standard ostomy pouches to see if it reduces complications after surgery. Patients will either get the new device or a regular dressing and will visit weekly for a month for check-ups including wound imaging and blood tests.

How Is the Trial Designed?

Group I: Limpet Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

Standard treatment with standard of care adhesive ostomy pouches.

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Published Research Related to This Trial

Advancements in surgical techniques since the 1950s have significantly reduced complications associated with ostomy surgery, highlighting the importance of ongoing support for patients' physical and psychological needs.

Despite the established practices in ostomy management, there is a lack of robust research and evidence-based guidelines, which could improve patient care and access to necessary interventions and supplies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ostomy care: foundation for teaching and practice. Turnbull, GB., Erwin-Toth, P.[2007]

The Esteem synergy device, evaluated in a 16-week study with 591 ostomized patients across Spain, received 'very good' ratings in effectiveness, safety, comfort, and quality of life impact, indicating strong performance in clinical practice.

Patients consistently rated the Esteem synergy system positively, suggesting it is a suitable option for both in-hospital and out-patient use for individuals with colostomies and ileostomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new system to treat ostomy in Spain]. [2006]

The adapted Ostomy Skin Tool for Brazilian culture demonstrated strong convergent validity, showing a positive correlation (r = 0.44) with pain intensity in patients with peristomal skin complications, indicating it effectively measures relevant clinical outcomes.

Interrater reliability was moderate to high (κ = 0.48-0.93) when nurses assessed peristomal skin conditions in a clinical setting, suggesting that the tool can be reliably used by different healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural Adaptation and Validation of the Ostomy Skin Tool to the Brazilian Portuguese. Nunes, MLG., Martins, L., Conceição de Gouveia Santos, VL.[2023]

The article introduces innovative one-piece compressible isolation devices designed to effectively manage the area around enteric fistulas, stomas, or drain tubes, helping to seal and protect patients from effluent.

These devices are the result of collaboration between an abdominal reconstructive surgeon and a Certified Wound Ostomy Nurse, aiming to enhance patient outcomes and reduce the clinical resources needed for managing these complex surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Compressible Barrier Devices for Enteric Fistula and Ostomy Effluent Isolation. Obst, MA., Dries, D.[2020]

An international group of ostomy nurse experts developed consensus-based practice guidelines aimed at reducing pouch leakage and improving the quality of life for individuals with ostomies.

The guidelines emphasize assessing body and stoma profiles to select the best pouching system, educating patients, and establishing follow-up protocols after hospital discharge or product changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Consensus Results: Development of Practice Guidelines for Assessment of Peristomal Body and Stoma Profiles, Patient Engagement, and Patient Follow-up. Colwell, JC., Bain, KA., Hansen, AS., et al.[2020]

In a study of 239 veterans with intestinal ostomies, factors such as age, income, employment, and preoperative care significantly influenced the severity of ostomy complications like skin irritation and leakage, with older age correlating with less severe issues.

Preoperative education and stoma site marking were associated with fewer complications and better adjustment to living with an ostomy, highlighting the importance of these practices in improving quality of life for ostomy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic and clinical factors related to ostomy complications and quality of life in veterans with an ostomy. Pittman, J., Rawl, SM., Schmidt, CM., et al.[2016]

The new fistula and wound management system was well-received by nurses, with 21 out of 22 expressing willingness to use it for future patients, indicating strong potential for clinical adoption.

Patients reported high mobility while using the new pouches (95% of the time) and the system demonstrated significantly longer wear time compared to traditional options, enhancing overall comfort and effectiveness in managing abdominal fistulas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of fistulae in the abdominal region. Hocevar, BJ., Erwin-Toth, P., Landis-Erdman, J., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06524401

Novel Post-Surgical Incision Management to Prevent ... The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, ...

2. withpower.com withpower.com/trial/phase-intestinal-fistula-7-2024-b2c67

Limpet Device for 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, ...

3. fistulasolution.com fistulasolution.com/breakthrough-device/

Fistula Solution Receives FDA Breakthrough Device ... “Early clinical results are promising and suggest our device reduces the complications typically associated with fistulas and ostomies and ...

4. healthpartners.com healthpartners.com/institute/research/studies/limpet-study-advancing-ostomy-and-enteric-fistula-care/

Limpet Study: Advancing Ostomy and Enteric Fistula Care Purpose of study: The purpose of the study is to determine if a new ostomy pouch wound management device, called the Limpet, prevents complications and ...

5. seed.nih.gov seed.nih.gov/portfolio/nih-portfolio-company-showcase/fistula-solution

Fistula Solution Up to 70% of ostomy patients endure these complications, with 29% of these patients requiring hospital readmissions at an additional cost of $78,000 per patient ...