Clinical Trial of Gastrostomy Button Securement Device

NCT04001946 | Completed FDA Device

• 1 other identifier: 18-1615
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Gastrostomy Complications

Keywords

Gastrostomy

Outcome Measures

Primary Outcomes (1)

• Reduction in G-button complications

  leakage, dislodgment, granulation tissue formation, and skin infection/irriation

  entire study (3 months after placement)

Secondary Outcomes (1)

• Caregiver Strain Index

  entire study (3 months after placement)

Study Arms (2)

G-button Securement Device

OTHER

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

Standard Dressing

NO INTERVENTION

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.

Interventions

Button Huggie DEVICE

low profile, external securement device for G-buttons

G-button Securement Device

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Phoenix Children's Hospital: collaborator
• Stanford University: collaborator
• University of Utah: collaborator

Study Sites (4)

Phoenix Children's

Phoenix, Arizona, 85016, United States

Location

Stanford Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Utah

Salt Lake City, Utah, 84113, United States

Location

Related Links

• Related Info

Study Officials

• Steve Moulton, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: June 28, 2019
• Study Start: January 30, 2023
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)