TubeClear System Evaluation in Pediatric Patients

NCT07570537 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00003989
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Behavioral Response

  Evaluating the behavioral response to the simultaneous noise and vibration in pediatric patients using behavioral score (0-5)

  Immediately following intervention and Days 1-3

Study Arms (1)

TubeClear

EXPERIMENTAL

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

Interventions

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.

TubeClear

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Central Study Contacts

Brenton Reading, MD

CONTACT

816-816-7823; bdreading@cmh.edu

Kacie Moon

CONTACT

816-816-7837; kamoon@cmh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04