Clinical Trial of Gastrostomy Button Securement Device

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).

Study Overview

• Status: Completed
• Conditions: Gastrostomy Complications
• Intervention / Treatment: Device: Button Huggie

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Lucile Packard Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: G-button Securement Device; Subjects will be provided instructions and a 12-week supply of test devices, sufficient to change the gauze dressing at least once per day.	Device: Button Huggie; low profile, external securement device for G-buttons
No Intervention: Standard Dressing; Subjects will be provided instructions and a 12-week supply of tape and gauze (current standard of care), sufficient to change the gauze dressing at least once per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in G-button complications	leakage, dislodgment, granulation tissue formation, and skin infection/irriation	entire study (3 months after placement)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Strain Index	Obtain feedback from parents and patients at four, eight, and twelve weeks on various aspects of the securement device Comfort, quality of materials, adhesiveness, ease of use, types and number of interactions with healthcare providers (phone calls, ED, and clinic visits)	entire study (3 months after placement)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Stanford University; University of Utah; Phoenix Children's Hospital
• Investigators: Principal Investigator: Steve Moulton, MD, University of Colorado, Denver

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): December 10, 2025
• Study Completion (Actual): December 10, 2025

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Gastrostomy
• Other Study ID Numbers: 18-1615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No