An interventional study of TubeClear® intervention in Enteral Nutrition, sponsored by Children's Hospital of Philadelphia. Terminated at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
This is the first of three planned phases designed to evaluate the feasibility and tolerability of TubeClear® to restore patency in occluded Pediatric Enteral Access Devices. Based on preliminary data obtained from this phase of the study, subsequent phases will continue to evaluate feasibility and tolerability (Phase IIA) and ultimately compare efficacy of TubeClear® to the Children's Hospital of Philadelphia (CHOP) Standard Treatment to restore patency in occluded Pediatric Enteral Access Devices (EAD) (Phase IIB).
Occluded enteral access devices (EADs) are a significant problem for pediatric patients, with occlusion rates ranging from 12.5% to 35%. Occluded EADs can lead to extended times of decreased energy intake, resulting in patients quickly exhausting their energy reserves and developing dehydration with electrolyte abnormalities. Current methods used to restore patency to an occluded EAD at The Children's Hospital of Philadelphia (CHOP) involve application of enzymes and chemicals (e.g., Clog Zapper), which have variable rates of timely success. If these methods are unsuccessful and patency cannot be restored, the EAD must be replaced and may require radiological intervention with exposure to radiation and contrast material. TubeClear® addresses this clinical need to safely and efficaciously restore patency to occluded EADs at the patients' bedside while the EAD remains in the patient. Additionally, this reduces the need to transport the patient to the radiology suite with subsequent exposure to radiation and contrast material for EAD location conformation after replacement.
Current Study (Phase I): Feasibility and tolerability of TubeClear® intervention in 15 consecutive eligible Subjects with occluded Enteral Access Devices who have not attained their 18th birthday.
Following successful completion of Phase I as deemed by the Institutional Review Board (IRB), the Study will proceed to Phase IIA and IIB to run concurrently.
Future Studies:
Phase IIA: Ability of TubeClear® intervention to restore patency in 15 consecutive eligible Subjects with occluded Enteral Access Devices who have not attained their 11th birthday.
Phase IIB: Randomized efficacy comparison between 17 subjects using the TubeClear® intervention and 17 subjects using CHOP Standard Treatment in eligible Subjects with occluded Enteral Access Devices who are between 11 years of age and have not attained their 18th birthday.
Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Indwelling occluded EAD(P) that is either:
Exclusion Criteria:
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.
Device: 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.
Number of Successful Attempts to Restore EAD(P) Patency
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.
Time frame: Baseline to 5 minutes post-intervention
Change in Age-Appropriate Pain Score
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
Time frame: Baseline to 3 days post-intervention
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.
| Milestone | TubeClear® (Phase I) |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Unable to clear indwelling feeding tube device | 1 |
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Collected over Time frame = 5 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TubeClear® (Phase I) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
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
| Age, Customized(Participants) | TubeClear® (Phase I) |
|---|---|
| Less than 18 years of age | 1 |
| Sex: Female, Male(Participants) | TubeClear® (Phase I) |
|---|---|
| Female | 1 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | TubeClear® (Phase I) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
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Children's Hospital of Philadelphia