Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT04001946 |
Other study ID # |
18-1615 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.