TubeClear® Evaluation in Pediatric Patients (Phase I)

NCT02724631 | Terminated Results DMC

• 2 other identifiers: 14-0114885R44HD065365-04
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Enteral Nutrition

Keywords

Clogged enteral access devices; Occluded enteral access device; Enteral nutrition; Enteral access device; Tube Feeding; Gastric Feeding Tubes

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 5 minutes post-intervention

Secondary Outcomes (1)

• Change in Age-Appropriate Pain Score

  Baseline to 3 days post-intervention

Study Arms (1)

TubeClear® (Phase I)

EXPERIMENTAL

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

Interventions

TubeClear® intervention 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.

TubeClear® (Phase I)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females between who have not attained their 18th birthday
• 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)

You may not qualify if:

• Ward of the state
• Positive pregnancy test/ Pregnant females
• Any active gastrointestinal abnormalities or malformations, including but not limited to infections, inflammation, obstruction and/or recent abdominal surgery or trauma
• Constant dependency on the EAD(P) for a glucose source (e.g. hyperinsulinism states)
• Unable to tolerate water volume needed for the EAD(P) flush
• Allergies to the contrast agent(s) used in post-Intervention radiological imaging
• Measured total length of EAD(P) less than 38 cm (15 inches) - from external port to EAD(P) distal end
• Unknown length of EAD(P)
• Attending physician declines enrollment based on clinical judgement
• Subject attains 18 years of age during study duration

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Actuated Medical, Inc.: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Limitations and Caveats

Study ended due to inability to recruit applicable subjects to trial the study intervention

Results Point of Contact

• Title: Sharon Y Irving
• Organization: Children's Hospital of Philadelphia

irvings@chop.edu

215 590-1000

Study Officials

• Vijay Srinivasan, MBBS, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 31, 2016
• Study Start: November 1, 2016
• Primary Completion: April 5, 2019
• Study Completion: July 7, 2020
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)