Clinical Trial of Gastrostomy Button Securement Device

Gastrostomy Complications Clinical Trial

Official title:

Clinical Trial of Gastrostomy Button Securement Device

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04001946
• Other study ID #: 18-1615
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Patients aged 31 days to 18 years old who present for surgical placement of a gastrostomy button (open, endoscopically, or laparoscopically).

• 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 admitted to the hospital with a pre-existing G-button for reasons unrelated to the G-button will be eligible for the study if they have complications with their current G-button site.

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

Related Conditions & MeSH terms

• Gastrostomy Complications

Intervention

Device:
• Button Huggie
low profile, external securement device for G-buttons

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Phoenix Children's	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in G-button complications	leakage, dislodgment, granulation tissue formation, and skin infection/irriation	entire study (3 months after placement)
Secondary	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)	entire study (3 months after placement)

External Links

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