New feeding tube holder aims to cut complications in kids
NCT ID NCT04001946
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new device called Button Huggie that secures gastrostomy buttons (feeding tubes) in children. The goal was to see if it reduces problems like leakage, tube dislodgement, skin irritation, and infection compared to standard dressings. 182 children aged 1 month to 18 years were randomly assigned to use the device or standard care, and outcomes were tracked over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Button Huggie (external securement device for G-buttons)
- What this could lead to
- If it works, this device could reduce common feeding tube complications, fewer hospital visits, and less stress for caregivers.
- What could go wrong
- This is a small, completed trial. The device may not work better than standard dressings, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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182 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Phoenix Children's
Phoenix, Arizona, 85016, United States
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Stanford Lucile Packard Children's Hospital
Palo Alto, California, 94304, United States
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University of Utah
Salt Lake City, Utah, 84113, United States
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