Status:
TERMINATED
Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
Lead Sponsor:
Johns Hopkins University
Conditions:
Feeding Tube
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration rate, and lower ra...
Eligibility Criteria
Inclusion
- Consecutive adult patients (18-80 years of age) with need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc).
- Ability to give informed consent.
Exclusion
- Unable to give informed consent
- Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- Acute gastrointestinal bleeding
- Coagulopathy defined by prothrombin time \< 50% of control; PTT \> 50 sec, or INR \> 1.5), on chronic anticoagulation, or platelet count \<50,000
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
- Cirrhosis with portal hypertension, varices, and/or ascites
- Allergy to egg
Key Trial Info
Start Date :
September 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01892267
Start Date
September 6 2013
End Date
December 1 2014
Last Update
May 17 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205