Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment (TvP)

University of Pittsburgh

Status and phase

Terminated

Phase 3

Conditions

Gastroesophageal Reflux Disease (GERD)

Treatments

Procedure: Transoral Incisionless Fundoplication

Drug: Proton Pump Inhibitors; active control

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00857597

D00668-01C

PRO08110069 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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