NCT00235677

Brief Summary

Aim: To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure. The hypotheses tested in this study were that active treatment would: 1) decrease the use of antisecretory medication, 2) decrease GERD symptoms, 3) improve quality of life, and 4) reduce esophageal acid exposure.

Trial Health

87
On Track

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 Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
Last Updated

October 10, 2005

Status Verified

July 1, 2005

First QC Date

October 6, 2005

Last Update Submit

October 6, 2005

Conditions

Gastroesophageal Reflux

Keywords

Endoscopic antireflux treatmentGERDSham-controlledEndocinch

Outcome Measures

Primary Outcomes (2)

  • Antisecretory drugs use

  • GERD symptoms (heartburn and regurgitation)

Secondary Outcomes (4)

  • Quality of life

  • 24-hr esophageal acid exposure

  • Esophageal manometry

  • Occurrence of adverse events

Interventions

Endoscopic gastroplicationPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • typical symptoms of GERD (i.e., heartburn, regurgitation) for \> 6 months,
  • pathological esophageal acid exposure after discontinuation of medical therapy, proven by ambulatory 24-hour pH-monitoring with \> 5% of time a pH \< 4 and a symptom-association probability \> 95% (19)
  • patients considered for non-medical therapy, i.e. unwillingness to take life-long medication in medically-responding disease, suffering from medication side-effects or medically-intractable disease and unwillingness to undergo surgery
  • willingness to accept a pre-treatment observation period of three months duration
  • written informed consent

You may not qualify if:

  • severe preexisting esophageal motility disorder (i.e., more than \>40% non-transmitted or simultaneous contractions during a short esophageal manometry study)
  • hiatal hernia (\> 3 cm in length)
  • history of antireflux or esophageal/gastric surgery
  • severe psychiatric disease
  • reflux esophagitis grade D (LA classification)
  • Barrett's esophagus with dysplasia
  • esophageal stenosis/malignancy
  • pregnancy or lactation
  • history of low therapeutic compliance
  • other severe comorbidity (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorder)
  • use of anticoagulant or immunosuppressive drugs
  • history of alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Gastroenterology, UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (4)

  • Schiefke I, Neumann S, Zabel-Langhennig A, Moessner J, Caca K. Use of an endoscopic suturing device (the "ESD") to treat patients with gastroesophageal reflux disease, after unsuccessful EndoCinch endoluminal gastroplication: another failure. Endoscopy. 2005 Aug;37(8):700-5. doi: 10.1055/s-2005-870128.

    PMID: 16032486BACKGROUND

  • Arts J, Lerut T, Rutgeerts P, Sifrim D, Janssens J, Tack J. A one-year follow-up study of endoluminal gastroplication (Endocinch) in GERD patients refractory to proton pump inhibitor therapy. Dig Dis Sci. 2005 Feb;50(2):351-6. doi: 10.1007/s10620-005-1610-4.

    PMID: 15745100BACKGROUND

  • Mahmood Z, McMahon BP, Arfin Q, Byrne PJ, Reynolds JV, Murphy EM, Weir DG. Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up. Gut. 2003 Jan;52(1):34-9. doi: 10.1136/gut.52.1.34.

    PMID: 12477756BACKGROUND

  • Swain P, Park PO, Mills T. Bard EndoCinch: the device, the technique, and pre-clinical studies. Gastrointest Endosc Clin N Am. 2003 Jan;13(1):75-88. doi: 10.1016/s1052-5157(02)00106-x.

    PMID: 12797428BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Matthijs P Schwartz, PhD, MD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Andre J Smout, PhD, MD

    UMC Utrecht

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

August 1, 2003

Study Completion

August 1, 2005

Last Updated

October 10, 2005

Record last verified: 2005-07

Locations

NL(1)