NCT00857597

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 30, 2018

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

March 4, 2009

Last Update Submit

March 28, 2018

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

GERDendoscopicfundoplicationProton Pump Inhibitorsheartburnanti-reflux surgery

Outcome Measures

Primary Outcomes (3)

  • GERD symptoms

    Baseline

  • GERD symptoms

    6 month follow-up

  • GERD symptoms

    12 month follow-up

Secondary Outcomes (4)

  • PPI usage

    at 0, 6 and 12 month follow- up

  • Lower esophageal acid exposure

    at 0, 6 and 12 month follow- up

  • Esophagitis

    at 0, 6 and 12 month follow- up

  • Rate of adverse events

    at 0, 6 and 12 month follow- up

Study Arms (2)

EsophyX

EXPERIMENTAL
Procedure: Transoral Incisionless Fundoplication

Proton Pump Inhibitors

ACTIVE COMPARATOR
Drug: Proton Pump Inhibitors; active control

Interventions

Transoral Incisionless FundoplicationPROCEDURE

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.

Also known as: TIF procedure, ELF procedure, Endoluminal fundoplication, Endoscopic fundoplication
EsophyX
Proton Pump Inhibitors; active controlDRUG

Proton Pump Inhibitors; active control

Also known as: Esomeprazole, Lansomeprazole, Omeprazole, Pantoprazole, Rabeprazole, Nexium, Prevacid, Dakar, Lanso, Lanzor, Prezal, Lanzol, Prilosec, Losec, Logastric, Protonix, Zurcal, Pantozol, Zurcale, Aciphex, Pariet
Proton Pump Inhibitors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Links

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburn

Interventions

Proton Pump InhibitorsEsomeprazoleOmeprazolePantoprazoleRabeprazoleLansoprazole4-nitro-3-dimethylaminopropiophenone

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Blair A Jobe, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

  • Nicole D Bouvy, MD, PhD

    University Hospital Maastricht, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 30, 2018

Record last verified: 2016-10

Locations

NL(1)