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

Primary Purpose

Gastroesophageal Reflux Disease, Hiatal Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TIF Procedure
Sponsored by
EndoGastric Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mt. Graham Regional Medical Center
  • Tempe St. Luke's Hospital
  • Swedish Medical Center and SurgOne P.C.
  • Munroe Regional Hospital
  • St Mary's Hospital
  • Livingston Hospital and Healthcare Services, Inc. CAH
  • The Surgeons Group of Baton Rouge
  • Allegan Surgical Associates
  • Crossville Medical Group
  • Ihde Surgical Group, PA
  • The University of Texas Health Science Center
  • Master Center for Minimally Invasive Surgery
  • Utah County Surgical Associates
  • Reston Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TIF Procedure

Arm 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.. .

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Elimination of Proton Pump Inhibitor (PPI) usage
Elimination of Proton Pump Inhibitor (PPI) usage
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.
Healing of reflux esophagitis
Healing of reflux esophagitis
Safety outcomes
Incidence of anticipated and unanticipated adverse events
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.

Full Information

First Posted
April 30, 2010
Last Updated
March 4, 2019
Sponsor
EndoGastric Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01118585
Brief Title
Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
Official Title
Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoGastric Solutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Hiatal Hernia
Keywords
GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIF Procedure
Arm Type
Other
Arm 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.. .
Intervention Type
Procedure
Intervention Name(s)
TIF Procedure
Other Intervention Name(s)
TIF - Transoral Incisionless fundoplication
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastroesophageal Reflux Disease (GERD) symptom elimination
Description
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).
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
Elimination of Proton Pump Inhibitor (PPI) usage
Description
Elimination of Proton Pump Inhibitor (PPI) usage
Time Frame
at 12-, 24- and 36-month follow-up
Title
Esophageal acid exposure
Description
Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4.
Time Frame
at 6-, 12-, 24- and 36-month follow-up
Title
Healing of reflux esophagitis
Description
Healing of reflux esophagitis
Time Frame
at 12, 24- and 36-month follow-up
Title
Safety outcomes
Description
Incidence of anticipated and unanticipated adverse events
Time Frame
first 30 days
Title
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
Description
GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.
Time Frame
at 12-, 24- and 36-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reginald CW Bell, MD, FACS
Organizational Affiliation
SurgOne P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mt. Graham Regional Medical Center
City
Safford
State/Province
Arizona
ZIP/Postal Code
85546
Country
United States
Facility Name
Tempe St. Luke's Hospital
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Swedish Medical Center and SurgOne P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Munroe Regional Hospital
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
St Mary's Hospital
City
Hobart
State/Province
Indiana
ZIP/Postal Code
46342
Country
United States
Facility Name
Livingston Hospital and Healthcare Services, Inc. CAH
City
Salem
State/Province
Kentucky
ZIP/Postal Code
42078
Country
United States
Facility Name
The Surgeons Group of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Allegan Surgical Associates
City
Allegan
State/Province
Michigan
ZIP/Postal Code
49010
Country
United States
Facility Name
Crossville Medical Group
City
Crossville
State/Province
Tennessee
ZIP/Postal Code
38555
Country
United States
Facility Name
Ihde Surgical Group, PA
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
The University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Master Center for Minimally Invasive Surgery
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Utah County Surgical Associates
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Reston Hospital
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.endogastricsolutions.com
Description
Click here for more information about this study: TIF Registry study

Learn more about this trial

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

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