Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)

Endogastric Solutions

Status

Completed

Conditions

Hiatal Hernia

Gastroesophageal Reflux Disease

Treatments

Procedure: TIF Procedure

Study type

Interventional

Funder types

Industry

Identifiers

NCT01118585

D00960

Details and patient eligibility

About

The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.

Full description

Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.

Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.

Enrollment

278 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-75 years
GERD for > 1 year
History of daily PPIs use for > 6 months
Moderate to severe typical or atypical GERD symptoms off PPIs
Complete (responders) or partial (nonresponders) symptom control on PPIs
Deteriorated gastroesophageal junction (Hill grade II or III)
Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing
Willingness to undergo pH/impedance testing, if required
Willingness to cooperate with the postoperative diet for 6 weeks
Availability for follow up visits at 6 months and 12 months
Willingly and cognitively signed informed consent

Exclusion criteria

BMI > 35
Incompletely reducible hiatal hernia with residual of > 5 mm
Esophagitis grade D
Barrett's Esophagus > 2 cm
Esophageal ulcer
Fixed esophageal stricture or narrowing
Portal hypertension and/or varices
Active gastro-duodenal ulcer disease
Gastric outlet obstruction or stenosis
Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study, if patient complains of postprandial satiety during assessment
Coagulation disorder
History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
Pregnancy or plans of pregnancy in the next 12 months
Enrollment in another device or drug study that may confound the results

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

278 participants in 1 patient group

TIF Procedure

Other group

Description:

Intervention: Transoral incisionless fundoplication procedure using the EsophyX device. During general anesthesia the EsophyX device is introduced trans orally into the stomach and used to created a 270 degree, 3cm in length, wrap at the distal end of the esophagus to treat GERD.. .

Treatment:

Procedure: TIF Procedure