NCT02724631

TubeClear® Evaluation in Pediatric Patients (Phase I)

Evaluation of Efficacy of Use of TubeClear® to Restore Patency to Occluded Enteral Access Devices in Pediatric Patients (Phase I)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Enteral Nutrition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-04-05
• Completion: 2020-07-07
• First posted: 2016-03-31
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

1 site across 1 country: United States