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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new device for feeding tubes aimed at preventing leaks in patients with long-term feeding tubes. The device attaches to the tube and reduces leaks and friction at the insertion site, potentially improving comfort and reducing infection risk.

Research Team

Eric Yudelevich, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+