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Gastroesophageal RefluxPhase 3NCT00235677

Treatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication, A Placebo-Controlled Study

A Phase 3 study testing Endoscopic gastroplication in people with Gastroesophageal Reflux, run by UMC Utrecht at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastroesophageal Reflux
What is being tested?
Endoscopic gastroplication
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteNetherlands
Study dates
Aug 2003to Aug 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Dept. of Gastroenterology, UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: A Blinded, Randomized, Sham-Controlled Trial of Endoscopic Gastroplication for the Treatment of Gastroesophageal Reflux Disease

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.

Read the detailed description

Gastroesophageal reflux disease (GERD) and the chronic, often lifelong, use of antisecretory medication have great clinical and economical implications for the patient, practicing physician and society in general. The currently available medication in GERD is very effective against heartburn, but less against the symptom of regurgitation. Surgical antireflux treatment offers a good alternative. The current surgical approach, a laparoscopic fundoplication, is safe and effective (a 90% reduction in use of antireflux medication), but in a significant subgroup of patients new symptoms arise (dysphagia, bloating) and perioperative morbidity, as well as financial costs are relatively high.

An endoscopic suturing system has been developed, offering a minimally invasive antireflux treatment, which can be performed in an outpatient setting. The procedure aims to create an endoscopic fundoplication, and could possibly serve as an alternative to antireflux medication and surgery. Recent, uncontrolled studies, have shown that the results of the endoscopic suturing system are satisfactory and that the procedure is safe.

This single-center, double-blinded, randomized, sham-controlled trial was conducted to evaluate the efficacy of endoscopic gastroplication by the Endocinch suturing system. Sixty patients with daily symptoms of GERD and abnormal esophageal 24-hr pH monitoring were randomly assigned to three endoscopic gastroplications (n = 20), to a sham procedure (n = 20) or to observation (n = 20). Primary endpoints were proton pump inhibitor use and GERD symptoms. Secondary endpoints were quality of life, 24-hr esophageal acid exposure, esophageal manometry and the occurrence of adverse events. Follow-up assessments were performed at 3 months. The research nurse and patients in the active and sham groups were blinded to the procedure assignment.

Being tested
Endoscopic gastroplication
Keywords
Endoscopic antireflux treatment, GERD, Sham-controlled, Endocinch
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic gastroplicationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antisecretory drugs use

  2. GERD symptoms (heartburn and regurgitation)

Secondary outcomes (4)

  1. Quality of life

  2. 24-hr esophageal acid exposure

  3. Esophageal manometry

  4. Occurrence of adverse events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2005 (estimated)
  2. Study startAug 2003
  3. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00235677
Sponsor's protocol ID
Endoplac
Status last verified
Jul 2005
First submitted
6 Oct 2005
Last updated
10 Oct 2005
Results posted
No

Publications

  • 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.

    PubMed 16032486

  • 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.

    PubMed 15745100

  • 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.

    PubMed 12477756

  • 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.

    PubMed 12797428

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endoscopic gastroplication in people with Gastroesophageal Reflux, run by UMC Utrecht at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antisecretory drugs use. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00235677, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2005; AzTrials last refreshed its copy on 8 Nov 2026.

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