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Not yet recruiting NCT07004400

A Blinded Randomized Clinical Study of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of GERD

No phase Interventional GERD (Gastroesophageal Reflux Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RefluxStop™ implantation, Nissen fundoplication.
Who it may be relevant to
Registry conditions: GERD (Gastroesophageal Reflux Disease). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Blinded Randomized Clinical Investigation of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of Gastroesophageal Reflux Disease (GERD).

Overview

This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.

Detailed description

This study is a post-market prospective, blinded, randomized, multicenter, multi-arm clinical investigation using standard clinical procedures to record data to evaluate the safety and performance of RefluxStop™ compared with standard Nissen fundoplication for the treatment of subjects suffering from GERD.

A randomization will be performed where the Subjects will be blinded as to assigned randomization group.

Interventions

  • Device RefluxStop™ implantation
    Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
  • Procedure Nissen fundoplication
    Standard surgical technique for Nissen fundoplication

Primary outcome measures

  • Patient Reported Outcomes - Side effects (PROS) evaluation [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Willing and able to provide informed consent and to participate in the clinical investigation;
  • Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
  • Documented GERD present for ≥ 12 months. Typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain;
  • 24-hour pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be < 4 for ≥ 4.5% of time during a 24-hour monitoring);
  • Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator

Exclusion criteria

  • > 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed;
  • Manometry verified lack of or moderate or severe weak peristalsis in esophagus with DCI <300 or pathologic LOS function including hypercontractability, spasm or pathologic nonrelaxing functionality (the latter defined as coordinated swallows in less than 70% of wet swallows or median IRP>15mmHg). Hypercontractability defined as DCI >8'000 or pressure >45 mmHg. Thus, excluding from the study the rare diseases achalasia, scleroderma, and nutcracker esophagus, however, including mild esophageal motility disorder patients with mildly weak peristalsis;
  • History of bariatric or anti-reflux surgery;
  • Female subjects who are pregnant or nursing;
  • Known sensitivity or allergies to silicone materials;
  • Intraoperative findings determined by the investigator that may result in unfavorable conduct of the clinical investigation procedure (as outlined in the IFU);
  • Subjects that are unable to comply with the clinical investigation requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 2 centers
  • St. Elisabethen Krankenhaus Frankfurt — Frankfurt
  • Klinikum Friedrichshafen GmbH — Friedrichshafen
Austria · 1 center
  • Universitätsklinik für Allgemeinchirurgie Klinische Abteilung für Viszeralchirurgie — Vienna
Switzerland · 1 center
  • Klinik Beau-Site Hirslanden Bern — Bern

Identifiers

NCT: NCT07004400 · RXI005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗