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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01118585
Other study ID # D00960
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2010
Est. completion date December 2018

Study information

Verified date March 2019
Source EndoGastric Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 278
Est. completion date December 2018
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Procedure:
TIF Procedure
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.

Locations

Country Name City State
United States Allegan Surgical Associates Allegan Michigan
United States Ihde Surgical Group, PA Arlington Texas
United States The Surgeons Group of Baton Rouge Baton Rouge Louisiana
United States Crossville Medical Group Crossville Tennessee
United States Swedish Medical Center and SurgOne P.C. Englewood Colorado
United States St Mary's Hospital Hobart Indiana
United States The University of Texas Health Science Center Houston Texas
United States Munroe Regional Hospital Ocala Florida
United States Utah County Surgical Associates Provo Utah
United States Reston Hospital Reston Virginia
United States Mt. Graham Regional Medical Center Safford Arizona
United States Livingston Hospital and Healthcare Services, Inc. CAH Salem Kentucky
United States Master Center for Minimally Invasive Surgery Southlake Texas
United States Tempe St. Luke's Hospital Tempe Arizona

Sponsors (1)

Lead Sponsor Collaborator
EndoGastric Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastroesophageal Reflux Disease (GERD) symptom elimination GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index). 6-month follow-up
Secondary Elimination of Proton Pump Inhibitor (PPI) usage Elimination of Proton Pump Inhibitor (PPI) usage at 12-, 24- and 36-month follow-up
Secondary Esophageal acid exposure Normalization of esophageal acid exposure is defined as = 4.3% of 24-hour period or = 5.3% of 48-hour period at pH < 4. at 6-, 12-, 24- and 36-month follow-up
Secondary Healing of reflux esophagitis Healing of reflux esophagitis at 12, 24- and 36-month follow-up
Secondary Safety outcomes Incidence of anticipated and unanticipated adverse events first 30 days
Secondary Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores. at 12-, 24- and 36-month follow-up
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