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

This study is currently recruiting participants.
Verified May 2013 by EndoGastric Solutions
Sponsor:
Information provided by (Responsible Party):
EndoGastric Solutions
ClinicalTrials.gov Identifier:
NCT01110811
First received: April 23, 2010
Last updated: February 10, 2014
Last verified: May 2013

April 23, 2010
February 10, 2014
April 2010
May 2014   (final data collection date for primary outcome measure)
Proportion of patients in clinical remission [ Time Frame: at 6 month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01110811 on ClinicalTrials.gov Archive Site
  • Reduction in symptoms [ Time Frame: at 6 moths follow-up ] [ Designated as safety issue: No ]
  • Normalized esophageal acid exposure [ Time Frame: at 6 months follow-up ] [ Designated as safety issue: No ]
  • Healed reflux esophagitis [ Time Frame: at 6 months follow-up ] [ Designated as safety issue: No ]
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Hiatal Hernia
Device: 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 esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.
    Intervention: Device: Transoral Incisionless Fundoplication (TIF)
  • Sham Comparator: Sham procedure
    Sham procedure consisting of upper GI endoscopy
    Intervention: Device: Transoral Incisionless Fundoplication (TIF)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2015
May 2014   (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
Both
18 Years to 80 Years
No
Contact: Lars Lundell, M.D. +46 8 585 805 49 Lars.lundell@karolinska.se
Belgium,   France,   Sweden
 
NCT01110811
D2009-10
No
EndoGastric Solutions
EndoGastric Solutions
Not Provided
Principal Investigator: Lars Lundell, M.D. Karolinska University, Huddinge Hospital, Stockholm, Sweden
EndoGastric Solutions
May 2013

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