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.

Study Overview

• Status: Not yet recruiting
• Conditions: Enteral Nutrition; Tube Feeding; Clogged Enteral Access Devices; Occluded Enteral Access Devices; Enteral Access Device; Gastric Feeding Tubes
• Intervention / Treatment: Device: TubeClear

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brenton Reading, MD; Phone Number: 816-816-7823; Email: bdreading@cmh.edu
• Study Contact Backup: Name: Kacie Moon; Phone Number: 816-816-7837; Email: kamoon@cmh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TubeClear; This is an open label study without a control group. It is designed to evaluate the safety and efficacy of TubeClear in patients with occluded (partial/sluggish or fully blocked) feeding tubes.	Device: TubeClear; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Response Assessment	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.	Immediately following intervention and Days 1-3

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00003989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes