NCT04001946

Clinical Trial of Gastrostomy Button Securement Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Gastrostomy button (G-button) is a small tube inserted into the stomach that is used to feed and provide medication to children who can not eat or take medication on their own. G-buttons are commonly placed through surgery. While G-buttons give access for caregivers to provide adequate nutrition, they also can have complications associated with them; including, but not limited to leakage, skin irritation or infection, and dislodgement. These complications can be a big burden for caregivers and medical providers causing extra clinic, ED visits, and increased cost. The investigators have designed a securement device for the gastrostomy button and want to compare the device to the standard securement method, which is tape and gauze dressing. The investigators believe that they will show 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). The investigators plan to get feedback from caregivers at 4, 8, and 12 weeks. The G-button securement device that is a Class II, 510(k) exempt medical device, subject to General Controls under Product Code PLI, regulated by 21 CFR 876.5980.

Conditions

• Gastrostomy Complications

Interventions

Type	Name	Description
DEVICE	Button Huggie	low profile, external securement device for G-buttons

Timeline

• Start date: 2023-01-30
• Primary completion: 2025-12-10
• Completion: 2025-12-10
• First posted: 2019-06-28
• Last updated: 2026-02-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study