Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
NCT ID: NCT00857597
Last Updated: 2018-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
60 participants
INTERVENTIONAL
2009-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EsophyX
Transoral Incisionless Fundoplication
The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference.
Proton Pump Inhibitors
Proton Pump Inhibitors; active control
Proton Pump Inhibitors; active control
Interventions
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Transoral Incisionless Fundoplication
The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference.
Proton Pump Inhibitors; active control
Proton Pump Inhibitors; active control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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EndoGastric Solutions
INDUSTRY
Sandhill Scientific
INDUSTRY
Crospon
INDUSTRY
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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Blair A Jobe, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Nicole D Bouvy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Maastricht, The Netherlands
Locations
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University Hospital Maastricht
Maastricht, Limburg, Netherlands
Countries
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Related Links
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Data reported in Am J Gastroenterol. 2015 Apr;110(4):531-42. doi: 10.1038/ajg.2015.28. Epub 2015 Mar 31.
Other Identifiers
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PRO08110069
Identifier Type: OTHER
Identifier Source: secondary_id
D00668-01C
Identifier Type: -
Identifier Source: org_study_id
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