Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 12:14 PM
Study NCT ID:
NCT07115134
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
Sponsor:
Children's National Research Institute
Organization:
Study Overview
Official Title:
Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tube Anchor
Brief Summary:
This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED/clinic visits for gastrostomy tube complications.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: