Clinical Trial of Gastrostomy Button Securement Device

Completed · Not applicable

Conditions studied: Gastrostomy Complications

In brief

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).

Key facts

Study ID

NCT04001946

Run by

University of Colorado, Denver

People needed

182

Starts

2023-01-30

Expected to finish

2025-12-10

Last updated by the study team

2026-02-17

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Children's — Phoenix, Arizona, United States
• Stanford Lucile Packard Children's Hospital — Palo Alto, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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