Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

NARecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

September 24, 2024

Primary Completion Date

December 18, 2027

Study Completion Date

December 18, 2027

Conditions
Gastroenterology SurgeryTube Feeding
Interventions
DEVICE

Bearables Gastrostomy Tube Dressing

"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."

Trial Locations (1)

20010

RECRUITING

Children's National Hospital, Washington D.C.

All Listed Sponsors
lead

Children's National Research Institute

OTHER