Clogged Enteral Access DevicesNCT07570537
TubeClear System Evaluation in Pediatric Patients
A study testing TubeClear in people with Clogged Enteral Access Devices and Occluded Enteral Access Devices, run by Children's Mercy Hospital Kansas City.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Clogged Enteral Access Devices, Occluded Enteral Access Devices, Enteral Nutrition
- What is being tested?
- TubeClear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Attending physician declines enrollment based on clinical judgment
- Subject turns 18 years of age during study duration
- Very low birth weight (<1.5kg)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- TubeClear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TubeClearDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TubeClear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately following intervention and Days 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clogged Enteral Access DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenton Reading, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570537
- Sponsor's protocol ID
- STUDY00003989
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TubeClear System Evaluation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07570537
- Acronym / sponsor ID
- STUDY00003989
- Conditions
- Clogged Enteral Access Devices, Occluded Enteral Access Devices, Enteral Nutrition, Enteral Access Device, Tube Feeding, Gastric Feeding Tubes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TubeClear | Experimental | Device: TubeClearThis 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. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TubeClearTubeClear 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. | Device | TubeClear |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing TubeClear in people with Clogged Enteral Access Devices and Occluded Enteral Access Devices, run by Children's Mercy Hospital Kansas City.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brenton Reading, MD (816-816-7823, bdreading@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Response Assessment (time frame: Immediately following intervention and Days 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.