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Device

TubeClear® for Feeding Tube Maintenance in Children

N/A

Waitlist Available

Led By Vijay Srinivasan, MD, MBBS

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females who have not attained their 18th birthday

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 5 minutes post-intervention

Awards & highlights

Study Summary

This trial is designed to see if a new medical device, TubeClear, is safe and effective at restoring patency (opening up) in children's feeding tubes.

Who is the study for?

This trial is for children under 18 with a blocked feeding tube (EAD) made of PVC or Polyurethane, sizes 6-8 Fr and lengths 38-140 cm. It's not for those with GI issues, recent belly surgery, pregnant girls, wards of the state, allergies to imaging contrast agents, tubes shorter than 38 cm or who need constant glucose via EAD.Check my eligibility

What is being tested?

The study tests TubeClear®, a device meant to clear blockages in pediatric feeding tubes. This Phase I trial assesses if it's safe and tolerable. Future phases will further test its safety and compare its effectiveness against standard treatments at CHOP.See study design

What are the potential side effects?

Since this is an initial phase focusing on feasibility and tolerability, specific side effects are not detailed but may include discomfort or pain where the feeding tube enters the body during the clearing process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 5 minutes post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 5 minutes post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5 minutes post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Successful Attempts to Restore EAD(P) Patency

Secondary outcome measures

Change in Age-Appropriate Pain Score

Trial Design

1Treatment groups

Experimental Treatment

Group I: TubeClear® (Phase I)Experimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

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

1,963 Previous Clinical Trials

2,674,726 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,581,288 Total Patients Enrolled

Actuated Medical, Inc.Industry Sponsor

2 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

TubeClear® (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02724631 — N/A

Enteral Nutrition Research Study Groups: TubeClear® (Phase I)

Enteral Nutrition Clinical Trial 2023: TubeClear® Highlights & Side Effects. Trial Name: NCT02724631 — N/A

TubeClear® (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02724631 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research opportunity extend to individuals under the age of 60?

"According to the requirements listed, this trial is open exclusively for patients aged 0-17. Additionally, there are 8 more trials that span ages under 18 and above 65."

Answered by AI

Is this investigation currently accepting volunteers?

"According to the information published on clinicaltrials.gov this trial is not presently recruiting any participants. Initially posted in November 2016, with its last update taking place in June 2022, it appears that there are no current openings for enrolment. However, at present 7 other trials remain open and actively looking for volunteers."

Answered by AI

What demographic are researchers seeking to recruit for this clinical experiment?

"This research endeavour is attempting to recruit 15 minors aged between 0 and 17, who have been prescribed nutrition through nasoduodenal, nasogastric or nasojejunal tubes. All participants must comply with the following conditions: their gender falls within male/female; they are yet to reach 18 years of age; Polyvinyl Chloride (PVC) & Polyurethane 6 - 8 Fr, 38 - 140 cm for ND & NJ tubes respectively; Corflo & Corpak MedSystems' products as a jejunal tube inserted via gastrostomy tube 6 - 8Fr, 38-140"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TubeClear® Evaluation in Pediatric Patients (Phase I)

2016. "TubeClear® Evaluation in Pediatric Patients (Phase I)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02724631.