TubeClear System Evaluation in Pediatric Patients (NCT07570537) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
TubeClear System Evaluation in Pediatric Patients
20 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
0 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavioral Response Assessment
Timeframe: Immediately following intervention and Days 1-3