Status:
TERMINATED
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
EndoGastric Solutions
Sandhill Scientific
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PP...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Proven gastroesophageal reflux (pH \< 4 for \> 4.3% time while off PPIs for 7-14 days)
- On daily PPIs for \> 1 year
- Recurrence of GERD symptoms (GERD-HRQL score difference of \> 10 between on and off PPIs)
- Normal or hypotonic LES resting pressure (5-40 mmHg)
- Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol
- Signed informed consent
Exclusion
- BMI \> 35
- Hiatal hernia \> 2 cm
- Esophagitis grade D
- Barrett's esophagus
- Esophageal stricture
- Esophageal ulcer
- Esophageal motility disorder
- Gastric motility disorder
- Prior splenectomy
- Gastric paralysis
- Pregnancy (in females)
- Immunosuppression
- ASA \> 2
- Portal hypertension
- Coagulation disorders
- Previous antireflux procedure
- Any other health condition, which the investigator believes would prevent the patient from completing the study
- Lack of fluency in English
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00857597
Start Date
March 1 2009
End Date
December 1 2011
Last Update
March 30 2018
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6229 HX