Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
This study is ongoing, but not recruiting participants.
Sponsor:
EndoGastric Solutions
Information provided by (Responsible Party):
EndoGastric Solutions
ClinicalTrials.gov Identifier:
NCT01118585
First received: April 30, 2010
Last updated: April 22, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease Hiatal Hernia |
Procedure: Transoral Incisionless Fundoplication (TIF) using EsophyX |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study |
Resource links provided by NLM:
Further study details as provided by EndoGastric Solutions:
Primary Outcome Measures:
- Gastroesophageal Reflux Disease (GERD) symptom elimination [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]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 [ Time Frame: at 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
- Esophageal acid exposure [ Time Frame: at 6-, 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]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 [ Time Frame: at 12, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
- Safety outcomes [ Time Frame: first 30 days ] [ Designated as safety issue: Yes ]Incidence of anticipated and unanticipated adverse events
- Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination [ Time Frame: at 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
TIF Procedure
TIF procedure using EsophyX
|
Procedure: Transoral Incisionless Fundoplication (TIF) using EsophyX
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118585
Locations
| United States, Arizona | |
| Mt. Graham Regional Medical Center | |
| Safford, Arizona, United States, 85546 | |
| Tempe St. Luke's Hospital | |
| Tempe, Arizona, United States, 85281 | |
| United States, Colorado | |
| Swedish Medical Center and SurgOne P.C. | |
| Englewood, Colorado, United States, 80110 | |
| United States, Florida | |
| Munroe Regional Hospital | |
| Ocala, Florida, United States, 34471 | |
| United States, Indiana | |
| St Mary's Hospital | |
| Hobart, Indiana, United States, 46342 | |
| United States, Kentucky | |
| Livingston Hospital and Healthcare Services, Inc. CAH | |
| Salem, Kentucky, United States, 42078 | |
| United States, Louisiana | |
| The Surgeons Group of Baton Rouge | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Michigan | |
| Allegan Surgical Associates | |
| Allegan, Michigan, United States, 49010 | |
| United States, Tennessee | |
| Crossville Medical Group | |
| Crossville, Tennessee, United States, 38555 | |
| United States, Texas | |
| Ihde Surgical Group, PA | |
| Arlington, Texas, United States, 76014 | |
| The University of Texas Health Science Center | |
| Houston, Texas, United States, 77030 | |
| Master Center for Minimally Invasive Surgery | |
| Southlake, Texas, United States, 76092 | |
| United States, Utah | |
| Utah County Surgical Associates | |
| Provo, Utah, United States, 84604 | |
| United States, Virginia | |
| Reston Hospital | |
| Reston, Virginia, United States, 20190 | |
Sponsors and Collaborators
EndoGastric Solutions
Investigators
| Principal Investigator: | Reginald CW Bell, MD, FACS | SurgOne P.C. |
More Information
Additional Information:
No publications provided
| Responsible Party: | EndoGastric Solutions |
| ClinicalTrials.gov Identifier: | NCT01118585 History of Changes |
| Other Study ID Numbers: | D00960 |
| Study First Received: | April 30, 2010 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by EndoGastric Solutions:
|
GERD Esophagitis Fundoplication Anti-reflux surgery PPI dependent |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Hernia Hernia, Hiatal Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pathological Conditions, Anatomical Hernia, Diaphragmatic |
ClinicalTrials.gov processed this record on May 16, 2013