Accessory for Feeding Tube Complications
(SSA Trial)

Recruiting in Palo Alto (17 mi)

Overseen byEric Yudelevich, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Eric Yudelevich

No Placebo Group

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.

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

+3 more

Exclusion Criteria

Patient requires formal sedation for tube changes

Non-English speaking patients

Pregnant Women

+11 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Stoma Site AccessoryExperimental Treatment1 Intervention

Stoma site accessory with enteral tube replacement procedure.