View Clinical Trial (Medical Research Study)
A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| 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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| NCT ID: |
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NCT00857597 |
| Primary Contact: |
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Principal Investigator
Blair A Jobe, MD
University of Pittsburgh
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15232
United States
Blair A Jobe, MD
Phone: 412-623-2025
Email: jobeba@upmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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