TubeClear® Evaluation in Pediatric Patients (Phase I)

NCT ID: NCT02724631

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-07-07

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TubeClear® intervention

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Males or females between who have not attained their 18th birthday

2. Indwelling occluded EAD(P) that is either:

• Nasoduodenal Tube (ND), Nasogastric Tube (NG), Nasojejunal Tube (NJ) composed of Polyvinyl Chloride (PVC) and Polyurethane 6 - 8 Fr, 38 - 140 cm cm; or
• Nasogastric Tube (NG) (Corflo, Corpak MedSystems) used as a jejunal tube inserted through a gastrostomy tube, 6 - 8 Fr, 38 - 140 cm
• GJ (AMT) 14 Fr, 38 - 140 cm (15 - 55 in)

Exclusion Criteria

1. Ward of the state

2. Positive pregnancy test/ Pregnant females

3. Any active gastrointestinal abnormalities or malformations, including but not limited to infections, inflammation, obstruction and/or recent abdominal surgery or trauma

4. Constant dependency on the EAD(P) for a glucose source (e.g. hyperinsulinism states)

5. Unable to tolerate water volume needed for the EAD(P) flush

6. Allergies to the contrast agent(s) used in post-Intervention radiological imaging

7. Measured total length of EAD(P) less than 38 cm (15 inches) - from external port to EAD(P) distal end

8. Unknown length of EAD(P)

9. Attending physician declines enrollment based on clinical judgement

10. Subject attains 18 years of age during study duration

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actuated Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vijay Srinivasan, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R44HD065365-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-011488

Identifier Type: -

Identifier Source: org_study_id