Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00857597

Acronym

TvP

Enrollment

Registered

2009-03-06

Start date

2009-03-31

Completion date

2011-12-31

Last updated

2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

GERD, endoscopic, fundoplication, Proton Pump Inhibitors, heartburn, anti-reflux surgery

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 (PPIs).

Interventions

PROCEDURETransoral 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.

DRUGProton Pump Inhibitors; active control

Proton Pump Inhibitors; active control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
GERD symptoms	Baseline

Secondary

Measure	Time frame	Description
PPI usage	at 0, 6 and 12 month follow- up	—
Lower esophageal acid exposure	at 0, 6 and 12 month follow- up	—
Esophagitis	at 0, 6 and 12 month follow- up	Percentage of Participants with Esophagitis (Los Angeles classification scale)
Rate of adverse events	at 0, 6 and 12 month follow- up	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026