View Clinical Trial (Medical Research Study)
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment - NCT00857597-15232(Clinical Trial 276656)
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Pittsburgh |
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State:
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PA |
| Zip Code: |
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15232 |
| Conditions: |
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Gastroesophageal Reflux Disease (GERD) |
| Purpose: |
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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 (PPIs).
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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 |
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| Study is available at: |
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University of Pittsburgh Medical Center
Pittsburgh, PA 15232
United States
Primary Contact:
Blair A Jobe, MD
Email: jobeba@upmc.edu
Phone: 412-623-2025 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
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