Clinical trial NCT02724631: TubeClear® Evaluation in Pediatric Patients (Phase I)
Official title: Evaluation of Efficacy of Use of TubeClear® to Restore Patency to Occluded Enteral Access Devices in Pediatric Patients (Phase I)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Enteral Nutrition
Keywords: Clogged enteral access devices
Occluded enteral access device
Enteral nutrition
Enteral access device
Tube Feeding
Gastric Feeding Tubes
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Actuated Medical, Inc.
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-03-31
Enrollment: 1
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Successful Attempts to Restore EAD(P) Patency
timeFrame: Baseline to 5 minutes post-intervention
Secondary outcomes:
measure: Change in Age-Appropriate Pain Score
timeFrame: Baseline to 3 days post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Vijay Srinivasan, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: