TerminatedNot Applicable

TubeClear® Evaluation in Pediatric Patients (Phase I)

Stopped: Unable to recruit; study determined not feasible to continue

United States1 participantsStarted 2016-11

Plain-language 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).

Who can participate

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males or females between who have not attained their 18th birthday
✓. Indwelling occluded EAD(P) that is either:

Exclusion criteria

✕. 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)

What they're measuring

Number of Successful Attempts to Restore EAD(P) Patency

Timeframe: Baseline to 5 minutes post-intervention

Trial details

NCT IDNCT02724631

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-05

Results submitted2025-02-17

View on ClinicalTrials.gov More Enteral Nutrition trials