Endoscopic Fundoplication Versus Proton Pump Inhibitors f... | NCT00857597

Studies
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

NCT00857597

Sponsor

University of Pittsburgh

Status

Terminated

Last Update Posted

Mar 30, 2018Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

Transoral Incisionless Fundoplication
Proton Pump Inhibitors; active control

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PRO08110069	Other Identifier	University of Pittsburgh

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated after unplanned interim analysis of single centre data and results were reported

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 4, 2009

First Submission Date that Met QC Criteria

Mar 4, 2009

First Posted Date

Mar 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2018

Last Update Posted Date

Mar 30, 2018Actual

Name	Class
EndoGastric Solutions	INDUSTRY
Sandhill Scientific	INDUSTRY
Crospon	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transoral Incisionless Fundoplication	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
GERD symptoms		Baseline
GERD symptoms		6 month follow-up
GERD symptoms		12 month follow-up

Secondary Outcomes

Measure	Description	Time Frame
PPI usage		at 0, 6 and 12 month follow- up
Lower esophageal acid exposure		at 0, 6 and 12 month follow- up
Esophagitis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Blair A Jobe, MD	University of Pittsburgh Medical Center	Principal Investigator
Nicole D Bouvy, MD, PhD	University Hospital Maastricht, The Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Maastricht		Maastricht	Limburg	6229 HX	Netherlands

References Module

Citations

Not provided

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D054328	Proton Pump Inhibitors
D064098	Esomeprazole
D009853	Omeprazole
D000077402	Pantoprazole
D064750	Rabeprazole
D064747	Lansoprazole
C021225	4-nitro-3-dimethylaminopropiophenone

ID	Term
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

ID	Term
D005764	Gastroesophageal Reflux
D006356	Heartburn