Trial record 1 of 1 for:    NCT01110811
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Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01110811
Recruitment Status : Unknown
Verified August 2016 by EndoGastric Solutions.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2010
Last Update Posted : August 15, 2016
Information provided by (Responsible Party):
EndoGastric Solutions

April 23, 2010
April 27, 2010
August 15, 2016
April 2010
September 2015   (Final data collection date for primary outcome measure)
Proportion of patients in clinical remission [ Time Frame: at 6 month follow-up ]
Same as current
Complete list of historical versions of study NCT01110811 on Archive Site
  • Reduction in symptoms [ Time Frame: at 6 moths follow-up ]
  • Normalized esophageal acid exposure [ Time Frame: at 6 months follow-up ]
  • Healed reflux esophagitis [ Time Frame: at 6 months follow-up ]
Same as current
Not Provided
Not Provided
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.

Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).

Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Hiatal Hernia
Procedure: Transoral Incisionless Fundoplication (TIF)
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.
  • Active Comparator: TIF procedure
    Transoral Incisionless Fundoplication (TIF)
    Intervention: Procedure: Transoral Incisionless Fundoplication (TIF)
  • Sham Comparator: Sham procedure
    Sham procedure consisting of upper GI endoscopy
    Intervention: Procedure: Transoral Incisionless Fundoplication (TIF)
Håkansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015 Dec;42(11-12):1261-70. doi: 10.1111/apt.13427. Epub 2015 Oct 13.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
March 2017
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-80 years
  • On daily PPIs for > 6 months
  • Documented PPI dependency
  • Persistent GERD symptoms without PPI therapy during the titration phase of the study
  • Evidence of two or more of the following while off PPI therapy (> 10 days):
  • Erosive esophagitis (Los Angeles grade A-C)
  • Abnormal ambulatory pH study
  • Moderate to severe GERD symptoms
  • Normal or near normal esophageal motility (by manometry)
  • Patient willing to cooperate with post-operative dietary recommendations and assessment tests
  • Signed informed consent

Exclusion Criteria:

  • BMI > 35
  • Hiatal hernia > 3 cm
  • Esophagitis LA grade D
  • Esophageal ulcer
  • Esophageal stricture
  • Barretts esophagus (Prague: C>1, M>2)
  • Esophageal motility disorder
  • Severe gastric paralysis
  • Pregnancy or plans for pregnancy in the next 12 months
  • Immunosuppression
  • ASA > 2
  • Portal hypertension and/or varices
  • History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
  • Active gastro-duodenal ulcer disease
  • Gastric outlet obstruction or stenosis
  • Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
  • Coagulation disorders
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Sweden
Not Provided
Not Provided
EndoGastric Solutions
EndoGastric Solutions
Not Provided
Principal Investigator: Lars Lundell, M.D. Karolinska University, Huddinge Hospital, Stockholm, Sweden
EndoGastric Solutions
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP