Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment (TvP)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by University of Pittsburgh.
Recruitment status was Recruiting

Sponsor:

Collaborators:

EndoGastric Solutions

Sandhill Scientific Inc.

Crospon

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00857597

First received: March 4, 2009

Last updated: April 17, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 4, 2009

Last Updated Date

April 17, 2009

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

GERD symptoms [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

GERD symptoms; a ≥ 50% improvement will represent a clinically significant improvement. Treatment success will be defined by a significantly (p < 0.05) higher number of patients with ≥ 50% improvement in the TIF group vs. PPI group. [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00857597 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PPI usage [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Lower esophageal acid exposure [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Healed reflux esophagitis [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Rate of adverse events [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

PPI usage; Treatment success will be defined by PPI discontinuation or a significantly higher number of patients (p<0,05) that has a reduction from "daily" to "none" or "occasional". [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Normalized acid exposure; Treatment success will be defined by a significantly (p < 0.05) higher number of patients with normalized acid exposure in the TIF group (OFF PPI) vs. PPI group (ON PPI). [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Healed reflux esophagitis; Healing of esophagitis will represent a clinically significant improvement. Treatment success will be defined by a significantly (p < 0.05) higher number of patients with healed esophagitis in the TIF group vs. PPI group. [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Rate of (serious)adverse event (AE & SAE), gastro intestinal symptoms. Equivalence in safety will be defined by not statistically different (p > 0.05) scores and AE and SAE occurrence rate between the TIF group vs. PPI group. [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

Official Title ^ICMJE

A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study

Brief Summary

The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gastroesophageal Reflux Disease (GERD)

Intervention ^ICMJE

Procedure: Transoral Incisionless Fundoplication
The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference.
Other Names:
- TIF procedure
- ELF procedure
- Endoluminal fundoplication
- Endoscopic fundoplication
Drug: Proton Pump Inhibitors; active control
Proton Pump Inhibitors; active control
Other Names:
- Esomeprazole
- Lansomeprazole
- Omeprazole
- Pantoprazole
- Rabeprazole
- Nexium
- Prevacid
- Dakar
- Lanso
- Lanzor
- Prezal
- Lanzol
- Prilosec
- Losec
- Logastric
- Protonix
- Zurcal
- Pantozol
- Zurcale
- Aciphex
- Pariet

Study Arm (s)

Experimental: EsophyX
Intervention: Procedure: Transoral Incisionless Fundoplication
Active Comparator: Proton Pump Inhibitors
Intervention: Drug: Proton Pump Inhibitors; active control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 18-75 years
Proven gastroesophageal reflux (pH < 4 for > 4.3% time while off PPIs for 7-14 days)
On daily PPIs for > 1 year
Recurrence of GERD symptoms (GERD-HRQL score difference of > 10 between on and off PPIs)
Normal or hypotonic LES resting pressure (5-40 mmHg)
Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol
Signed informed consent

Exclusion Criteria:

BMI > 35
Hiatal hernia > 2 cm
Esophagitis grade D
Barrett's esophagus
Esophageal stricture
Esophageal ulcer
Esophageal motility disorder
Gastric motility disorder
Prior splenectomy
Gastric paralysis
Pregnancy (in females)
Immunosuppression
ASA > 2
Portal hypertension
Coagulation disorders
Previous antireflux procedure
Any other health condition, which the investigator believes would prevent the patient from completing the study
Lack of fluency in English

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00857597

Other Study ID Numbers ^ICMJE

D00668-01C

Has Data Monitoring Committee

Yes

Responsible Party

Blair A Jobe, MD, University of Pittsburgh Medical Center

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

EndoGastric Solutions
Sandhill Scientific Inc.
Crospon

Investigators ^ICMJE

Principal Investigator:	Blair A Jobe, MD	University of Pittsburgh
Principal Investigator:	Nicole D Bouvy, MD, PhD	University Hospital Maastricht, The Netherlands

Information Provided By

University of Pittsburgh

Verification Date

April 2009

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

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