← Back to Search

Device

G-button Securement Device for Gastrostomy Complications

N/A
Waitlist Available
Led By Steve Moulton, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Patients aged 31 days to 18 years old who present for surgical placement of a gastrostomy button (open, endoscopically, or laparoscopically).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entire study (3 months after placement)
Awards & highlights

Study Summary

This trial will compare a new gastrostomy button securement device to the standard dressing to see if there is a reduction in post-operative complications.

Who is the study for?
This trial is for patients aged 1 month to 18 years with a pre-existing gastrostomy button (G-button), who are experiencing complications or need a replacement. It's open to those visiting the clinic or hospitalized for unrelated reasons but have G-button issues. Excluded are those without reachable guardians, prisoners, pregnant women, and anyone unable to consent.Check my eligibility
What is being tested?
The study tests a new device called 'Button Huggie' designed to secure G-buttons against common problems like skin irritation and tube dislodgement. Participants will be randomly assigned to either use this new device or continue with standard dressings as control.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of attachment, possible skin reactions from the material of the Button Huggie, or an allergic response if sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a G-button that needs replacement or is causing complications.
Select...
I am between 31 days and 18 years old and need surgery for a feeding tube placement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entire study (3 months after placement)
This trial's timeline: 3 weeks for screening, Varies for treatment, and entire study (3 months after placement) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in G-button complications
Secondary outcome measures
Caregiver Strain Index

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: G-button Securement DeviceExperimental Treatment1 Intervention
Subjects will be provided instructions and a 12-week supply of test devices, sufficient to change the gauze dressing at least once per day.
Group II: Standard DressingActive Control1 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.

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalOTHER
74 Previous Clinical Trials
5,013,815 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,383 Total Patients Enrolled
1 Trials studying Gastrostomy Complications
24 Patients Enrolled for Gastrostomy Complications
Steve Moulton, MDPrincipal InvestigatorUniversity of Colorado, Denver
7 Previous Clinical Trials
1,448 Total Patients Enrolled

Media Library

Button Huggie (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04001946 — N/A
Gastrostomy Complications Research Study Groups: G-button Securement Device, Standard Dressing
Gastrostomy Complications Clinical Trial 2023: Button Huggie Highlights & Side Effects. Trial Name: NCT04001946 — N/A
Button Huggie (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04001946 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I fulfill the criteria necessary to join this clinical study?

"This clinical trial is enlisting participants aged between 1 month and 18 years with an existing gastrostomy. To qualify, individuals must have been admitted to the hospital for a pre-existing G-button issue unrelated to their condition, be seeking surgical placement of one such button, or require replacement/maintenance on their current device."

Answered by AI

Is there availability for participants to join this clinical experiment?

"This medical trial, which was first posted on October 1st 2022 and last updated 6 weeks later, is not currently enrolling patients. However, there are other clinical trials with available slots for participants to join."

Answered by AI

Are the elderly being considered for this clinical experiment?

"According to the requirements of this medical trial, infants aged 1 month and those no older than 18 years are eligible for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Clinical Trial of Gastrostomy Button Securement Device
2023. "Clinical Trial of Gastrostomy Button Securement Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04001946.
~57 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top