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TubeClear System Evaluation in Pediatric Patients

NCT07570537 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-31
Completion
2028-06-01
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570537 on ClinicalTrials.gov