Gastrostomy ComplicationsNCT04001946
Clinical Trial of Gastrostomy Button Securement Device
A study testing Button Huggie in people with Gastrostomy Complications, run by University of Colorado, Denver at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Gastrostomy Complications
- What is being tested?
- Button Huggie
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Jan 2023to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Stanford Lucile Packard Children's Hospital
Palo Alto, California, 94304
Phoenix Children's
Phoenix, Arizona, 85016
University of Utah
Salt Lake City, Utah, 84113
About this study
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).
Read the 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
- Being tested
- Button Huggie
- Keywords
- Gastrostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Button HuggieDevice
low profile, external securement device for G-buttons
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in G-button complications
leakage, dislodgment, granulation tissue formation, and skin infection/irriation
Measured: entire study (3 months after placement)
Secondary outcomes (1)
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)
Measured: entire study (3 months after placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start30 Jan 2023
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrostomy ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Phoenix Children's Hospital, Stanford University, University of Utah
- Responsible party
- Sponsor
- Investigators
- Steve Moulton, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001946
- Sponsor's protocol ID
- 18-1615
- Status last verified
- Feb 2026
- First submitted
- 8 May 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Gastrostomy Button Securement Device
- ClinicalTrials.gov ID
- NCT04001946
- Acronym / sponsor ID
- 18-1615
- Conditions
- Gastrostomy Complications
- Keywords
- Gastrostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Phoenix Children's Hospital, Stanford University, University of Utah
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-button Securement Device | Other | Device: Button HuggieSubjects will be provided instructions and a 12-week supply of test devices, sufficient to change the gauze dressing at least once per day. |
| 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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Button Huggielow profile, external securement device for G-buttons | Device | G-button Securement Device |
Primary outcome
Reduction in G-button complications
Time frame: entire study (3 months after placement)
leakage, dislodgment, granulation tissue formation, and skin infection/irriation
1 secondary outcome
Caregiver Strain Index
Time frame: entire study (3 months after placement)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Moulton, MD principal investigator
University of Colorado, Denver
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Button Huggie in people with Gastrostomy Complications, run by University of Colorado, Denver at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in G-button complications (time frame: entire study (3 months after placement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.