Accessory for Feeding Tube Complications

(SSA Trial)

Overseen By Linda Libertini, CRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eric Yudelevich

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: BMI ≥ 40, Pregnant, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new accessory designed to prevent leaks around long-term feeding tubes. The focus is on ensuring the safety and effectiveness of this accessory for individuals with existing gastrostomy or jejunostomy tubes, which have been in place for at least three months and need replacement. Participants must communicate in English, follow instructions, and not require general anesthesia for tube changes. The Stoma Site Enteral Feeding Tube Accessory could potentially improve comfort for those managing feeding tubes. As an unphased trial, this study offers participants the chance to contribute to innovative solutions that could enhance daily life for individuals with feeding tubes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using steroids or immunosuppressants.

What prior data suggests that this accessory is safe for preventing abdominal wall leakage?

Research shows that the stoma site enteral feeding tube accessory, tested to prevent leaks in patients with long-term feeding tubes, is being used in humans for the first time as intended. Since this accessory resembles other FDA-approved parts, it is expected to be safe when used correctly.

However, because this specific accessory is new to human use, direct safety data is not yet available. Generally, for similar procedures, serious complications occur in a small percentage of cases, between 0.4% and 4.4%. These complications can include leakage around the tube entry site.

This trial is labeled as "Not Applicable," indicating it doesn't fit into the usual clinical trial phases. This often means the treatment is new to human testing, and more data is needed to confirm its safety. Participants in the trial will provide important information about how well this accessory is tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Stoma Site Enteral Feeding Tube Accessory is unique because it offers a novel approach to addressing complications at the stoma site where feeding tubes are inserted. Unlike traditional options that mainly focus on managing issues after they arise, this accessory is designed to proactively prevent complications by providing enhanced stability and protection for the feeding tube. This proactive approach could potentially reduce the need for frequent tube replacements and minimize discomfort for patients, making it a promising development in the care of individuals relying on enteral feeding. Researchers are excited about the potential of this accessory to improve the quality of life for patients by reducing common issues associated with feeding tubes.

What evidence suggests that this accessory is effective for preventing abdominal wall leakage?

Research shows that the stoma site accessory, which trial participants will receive, is designed to prevent leaks around the area where long-term feeding tubes are inserted into the abdomen. Although this accessory is new and will be used in humans for the first time, it is based on parts already approved by the FDA and used in other feeding tube systems. Similar accessories have effectively stabilized and enhanced the function of feeding tubes. Feeding tubes themselves help maintain good nutrition and improve patients' quality of life. While specific data for this new accessory is not yet available, it is built on a proven method for safely managing feeding tubes. ^{3 4 5 6 7}

Who Is on the Research Team?

Eric Yudelevich, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 22 to 85 who have had a gastrostomy or jejunostomy feeding tube for at least 3 months and are scheduled for a tube replacement. Participants must understand the study, consent in writing, be able to take their temperature as required, and commit to follow-up procedures. Excluded are those needing sedation for tube changes, non-English speakers, pregnant women, people allergic to silicone, steroid or immunosuppressant users, recent participants in other trials, those unable to self-report or perform self-care.

Inclusion Criteria

Male or female, aged ≥22 and ≤85

Ability to understand and the willingness to sign a written informed consent document

Patients with existing gastrostomy and jejunostomy enteral feeding tubes, placed ≥ 3 months, undergoing replacement of feeding tube inpatient or outpatient

Exclusion Criteria

Patient requires formal sedation for tube changes

Non-English speaking patients

Pregnant Women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study stoma site accessory during a feeding tube replacement procedure

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with quality of life assessments

6 months

Monthly visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Stoma Site Enteral Feeding Tube Accessory

Trial Overview The trial tests a new stoma site accessory designed by Cleveland Clinic intended to prevent leakage around long-term feeding tubes. It's being compared with standard care during routine feeding tube replacements. The accessory is similar to FDA-approved components used with gastrostomy and jejunostomy tubes.

How Is the Trial Designed?

Group I: Stoma Site Accessory Experimental Treatment 1 Intervention

Stoma site accessory with enteral tube replacement procedure.

Who Is Running the Clinical Trial?

Eric Yudelevich

Lead Sponsor

Trials

1

Recruited

10+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05288556

Safety and Efficacy of Enteral Feeding Tube Stoma Site ... The purpose of the study is to collect safety and efficacy data on the performance of the study stoma site accessory when used to prevent abdominal wall leakage ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/56/NCT05288556/Prot_SAP_000.pdf

SINGLE SITE, PROSPECTIVE, PHASE I STUDY, SAFETY ... feeding tube stoma site accessory for patients with enteral feeding tubes. Primary. Endpoints. Safety and efficacy of the study stoma site ...

3. app.trialscreen.org app.trialscreen.org/trials/feeding-tube-complication-safety-efficacy-enteral-stoma-site-accessory-trial-nct05288556

Safety and Efficacy of Enteral Feeding Tube Stoma Site ... A study is being conducted to measure the safety and effectiveness of the Enteral Feeding Tube Stoma Site Accessory in preventing abdominal ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6566785/

The Effect of Enteral Tube Feeding on Patients' Health ... Enteral tube feeding has been shown to promote nutritional status, improve wound healing, and enhance patients' quality of life (QoL).

5. rockfieldmd.com rockfieldmd.com/news/nutrition-quality-of-life.html

The Effect of Enteral Tube Feeding on Patients' Health ... Overall, nine studies reported improvement in the QoL of patients on enteral tube feeding, while five studies demonstrated either no significant ...

6. asge.org asge.org/docs/default-source/education/Technology_Reviews/doc-enteral-nutrition-access-devices.pdf?sfvrsn=4

Enteral nutrition access devices A safe location for PEG tube placement is deter- mined by transillumination on the abdominal wall with the endoscopic light and confirmed by finger indenta-.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4093701/

Gastroenteric tube feeding: Techniques, problems and ... Serious complications requiring further intervention have been reported in 0.4%-4.4% of procedures and include peristomal leakage with peritonitis, necrotizing ...