CompletedNot Applicable

Clinical Trial of Gastrostomy Button Securement Device

United States182 participantsStarted 2023-01-30

Plain-language summary

Gastrostomy button (G-button) complications, such as granulation tissue formation, tube dislodgements, leakage, skin irritation or infection are frequent causes of post-operative clinic and emergency department visits. The investigators have developed a G-button securement device that they believe will have a significant reduction in the complications listed above. The investigators plan to randomized 200 patients to either the new securement device (treatment group) or the standard dressing (control group).

Who can participate

Age range1 Month – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 31 days to 18 years old who present for surgical placement of a gastrostomy button (open, endoscopically, or laparoscopically). * Patient weight is ≥ 4kg. Exclusion Criteria: * Refusal who object at any time to participate in the study * Those whose parents or legal guardians cannot be reached by telephone * Prisoners * Pregnant women * Impaired decision making capacity * Any patient with a pre-existing G-button who presents to the G-button or surgery clinic for G-button replacement or have complications associated with the G-button at any of study site locations.

What they're measuring

Reduction in G-button complications

Timeframe: entire study (3 months after placement)

Trial details

NCT IDNCT04001946

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-10

View on ClinicalTrials.gov More Gastrostomy Complications trials