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NCT04001946 · ClinicalTrials.gov registry record · NA
Clinical Trial of Gastrostomy Button Securement Device
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 182
- Enrollment target
NCT04001946: Completed NA study, sponsored by University of Colorado, Denver.
NCT04001946 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 182 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04001946, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
Study 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).
Primary Outcome
leakage, dislodgment, granulation tissue formation, and skin infection/irriation
Interventions
- DEVICE Button Huggie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2023-01-30 |
| Est. Completion | 2025-12-10 |
| Phase | NA |
What the finished NCT04001946 record still lists
NCT04001946 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Button Huggie is the first listed.
NCT04001946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04001946 about?
NCT04001946 is a clinical study titled "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 w...
What is the current status of trial NCT04001946?
This trial is currently completed. It is a NA study. The enrollment target is 182 participants. The study started on 2023-01-30. Estimated completion is 2025-12-10.
What interventions are being tested in trial NCT04001946?
The interventions under investigation include: Button Huggie (DEVICE).
Who is sponsoring clinical trial NCT04001946?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04001946's enrollment target sits among peer trials
182 584th of 2000 higher than 1,415 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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