TubeClear System Evaluation in Pediatric Patients

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.

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Key information

Conditions

Clogged Enteral Access Devices Enteral Access Device Enteral Nutrition Gastric Feeding Tubes Occluded Enteral Access Devices Tube Feeding

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
Specific GJ tubes: G-Jet, MIC, and MIC-KEY Tubes that are size 14-22Fr and have a jejunal length of 15-45cm

Exclusion criteria

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
Unable to tolerate water volume needed for EAD flush
Unknown length of EAD
Attending physician declines enrollment based on clinical judgment
Subject turns 18 years of age during study duration
Very low birth weight (<1.5kg)

Treatment and study plan

TubeClear

Device

TubeClear is comprised of a reusable Control Box and single-use Clearing Stem. The Clearing Stem is inserted into the patient's EAD, where the Control Box (when turned on) supplies mechanical actuation to the Clearing Stem. The mechanical actuation breaks up partial and/or full occlusions in EADs to restore full patency of EADs.

Primary outcomes

Behavioral Response Assessment

Time frame: Immediately following intervention and Days 1-3

Evaluating the behavioral response to the simultaneous noise and vibration in pediatric patients using behavioral score (0 being minimum score-5 being maximum score). Higher score equals a greater behavioral response.

Study contacts

Contact information is provided by the study sponsor or research team.

Brenton Reading, MD

CONTACT

[email protected]

816-816-7823

Kacie Moon

CONTACT

[email protected]

816-816-7837

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: May 6, 2026
Registry last updated: Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed