GERD Clinical Trial
Official title:
Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study
Verified date | June 2013 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach.
Status | Terminated |
Enrollment | 7 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - age 18-90 years - 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 for the study Exclusion Criteria: - patients with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000) - inability to get informed consent for the study from patients or their families - pregnancy (all women of child-bearing age will undergo urine pregnancy testing) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | GI Supply |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: Number of Participants with Adverse Events | Complications as a result of the PEGJ will be assessed (pain, vomiting, nausea) | From date of PEGJ placement up to 3 weeks | Yes |
Secondary | Migration of PEGJ feeding tube | Risk of retrograde migration within 3 weeks of placement | From date of PEGJ placement up to 3 weeks | No |
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