TubeClear® Evaluation in Pediatric Patients (Phase I)

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.

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