Trial Outcomes & Findings for TubeClear® Evaluation in Pediatric Patients (Phase I) (NCT NCT02724631)
NCT ID: NCT02724631
Last Updated: 2025-03-07
Results Overview
Feasibility will be defined as ability of the user to operate TubeClear® from clearing stem insertion into the occluded Enteral Access Device through activation to patency restoration. Successful restoration of patency will be defined as the ability to flush the EAD(P) with 10ml of air within five minutes following the intervention by the investigator.
TERMINATED
NA
1 participants
Baseline to 5 minutes post-intervention
2025-03-07
Participant Flow
Subjects are pediatric patients (Less than age 18) and are admitted to the Children's Hospital of Philadelphia (CHOP) Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU), or Interventional Radiology (IR) with an existing or a newly inserted Pediatric Enteral Access Device (EAD(P)) that becomes occluded. Occlusion is defined by direct identification of a clog or through a feeding pump alarm that sounds when patency of an EAD(P) is disrupted.
Only 1 participant was enrolled. Unable to restore patency to indwelling feeding device. The study was terminated due to lack of enrollment; insufficient data for analysis to assess outcome or draw conclusions from the intervention.
Participant milestones
| Measure |
TubeClear® (Phase I)
To determine feasibility and tolerability, 15 subjects will receive the TubeClear® intervention. If the TubeClear® intervention is unable to restore Enteral Access Device patency, further steps to restore patency of the occluded EAD will be determined by the clinical team per usual practice.
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
TubeClear® (Phase I)
To determine feasibility and tolerability, 15 subjects will receive the TubeClear® intervention. If the TubeClear® intervention is unable to restore Enteral Access Device patency, further steps to restore patency of the occluded EAD will be determined by the clinical team per usual practice.
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|---|---|
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Overall Study
unable to clear indwelling feeding tube device
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1
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Baseline Characteristics
TubeClear® Evaluation in Pediatric Patients (Phase I)
Baseline characteristics by cohort
| Measure |
TubeClear® (Phase I)
n=1 Participants
To determine feasibility and tolerability, 15 subjects will receive the TubeClear® intervention. If the TubeClear® intervention is unable to restore Enteral Access Device patency, further steps to restore patency of the occluded EAD will be determined by the clinical team per usual practice.
TubeClear® intervention: The TubeClear® device is deemed by the Food and Drug Administration (FDA) to be non-significant risk (NSR) for use in this study. It is a control box and a single use clearing stem used to resolve the clog in an enteral access device within five minutes following the intervention.
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|---|---|
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Age, Customized
Less than 18 years of age
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1 Participants
n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline to 5 minutes post-interventionPopulation: Only 1 participant was enrolled. Unable to restore patency to indwelling feeding device. The study was terminated due to lack of enrollment; insufficient data for analysis to assess outcome or draw conclusions from the intervention.
Feasibility will be defined as ability of the user to operate TubeClear® from clearing stem insertion into the occluded Enteral Access Device through activation to patency restoration. Successful restoration of patency will be defined as the ability to flush the EAD(P) with 10ml of air within five minutes following the intervention by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 3 days post-interventionPopulation: Only 1 participant was enrolled. Unable to restore patency to indwelling feeding device. The study was terminated due to lack of enrollment; insufficient data for analysis to assess outcome or draw conclusions from the intervention.
Tolerability will be defined as ability of the subject to undergo TubeClear® intervention. To assess this, subject pain will be assessed before and after use of TubeClear® intervention and then daily for up to 3 days post-intervention using one of the well-established age-appropriate pain scales. Based on subject age, one of the following pain scale assessments will be used: Face, Legs, Activity, Cry, Consolability (FLACC) Scale; Revised Face, Legs, Activity, Cry, Consolability (rFLACC) scale; FACES pain scale revised (FPS-R); Numeric Pain Scale; or Nursing Judgement
Outcome measures
Outcome data not reported
Adverse Events
TubeClear® (Phase I)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place