Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

NCT07115134 | Recruiting FDA Device

• 1 other identifier: STUDY00001158
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenterology Surgery; Tube Feeding

Outcome Measures

Primary Outcomes (2)

• Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement

  Current rates of gastrostomy tube complications and dislodgement will be evaluated with our retrospective review, then compared to rates of complications and dislodgement after our novel dressing placement. This was chosen as complications after gastrostomy tube placement are high, and we believe that our dressing will lower them.

  Up to one year

• Gastrostomy tube complications

  Up to one year

Study Arms (1)

Bearables Gastrostomy Tube Dressing Prototype

EXPERIMENTAL

Device: Bearables Gastrostomy Tube Dressing

Interventions

Bearables Gastrostomy Tube Dressing DEVICE

The gastrostomy tube dressing in its current design is composed of two parts, both of which are external to the patient: one part is rigid and holds the gastrostomy at a fixed position, this is a 3D printed design that is produced here. The second part is a 3" x 3" flexible, cushioned, biocompatible adhesive bandage designed to fit around the skin opening (Silicone Foam Dressing, NH NeuHeils, USA). The design is subject to minor changes including the number of parts and location with the structure of the padding and securement but will continue to be designed with comfort as a priority. After assembly, the device is packaged (sterilization pouches, Plastcareusa, USA), sealed, and sanitized using UV light prior to patient use.

Bearables Gastrostomy Tube Dressing Prototype

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.

You may not qualify if:

• \. Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Central Study Contacts

Anthony Sandler

CONTACT

202-476-5760; asandler@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 11, 2025
• Study Start: September 24, 2024
• Primary Completion (Estimated): December 18, 2027
• Study Completion (Estimated): December 18, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)