TubeClear System Evaluation in Pediatric Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorChildren's Mercy Hospital Kansas City

About this trial

Enteral access devices (EADs) provide necessary hydration, nutrition, and medications to numerous patients in hospitals across the United States. When patient's EAD becomes clogged it can delay administration of important nutrition and medications which can cause adverse effects such as malnutrition, and dehydration, especially in pediatric patients. Traditional methods of unclogging EADs can require the use of special enzymes or chemicals but these produce a variable rate of success. The TubeClear system has been developed to help alleviate the need for use of special enzymes or chemicals and to provide a quick, safe alternative for those with a clogged or sluggish EAD all while at the patient's bedside. This system prevents the need for subsequent exposure to radiation and contrast media for confirmation of EAD location after replacement.

Eligibility criteria

Qualifiers

Males or females under the age of 18 for the entire duration of the study procedure and follow up with an occluded (partial/sluggish or fully blocked) EAD

Indwelling EAD must be NE, NG, NJ tube composed of PVC or polyurethane and is 6-18 FR, 38-140 cm

NG tube being used as a J tube inserted through a G tube and is 6-18 Fr; 38-140 cm

G and J tubes 10-18 Fr; 20-36cm

Disqualifiers

Wards of the State

Positive urine pregnancy test/pregnant females or inability to take a pregnancy test

Any active gastrointestinal abnormalities, including but not limited to infections, inflammation, and/or recent abdominal surgery (except for recent gastrostomy placement) or trauma

Constant dependency on the EAD for glucose source

Trial design

Treatments tested in this trial

  • TubeClear

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations