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

NCT07004400 | Not Yet Recruiting DMC

• 1 other identifier: RXI005
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

GERD (Gastroesophageal Reflux Disease)

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcomes - Side effects (PROS) evaluation

  Patient Reported Outcomes - Side effects (PROS) evaluation at 6 months, combining the well-established side effects of traditional surgical treatment methods: * Dysphagia - swallowing difficulties; * Odynophagia - pain at swallowing; * Inability to belch and inability to vomit; and * Worsening of gas bloating compared to baseline;

  6 months

Study Arms (2)

RefluxStop™ device implantation

ACTIVE COMPARATOR

Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use

Device: RefluxStop™ implantation

Nissen fundoplication surgery

ACTIVE COMPARATOR

Standard surgical technique of Nissen fundoplication

Procedure: Nissen fundoplication

Interventions

RefluxStop™ implantation DEVICE

Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use

RefluxStop™ device implantation

Nissen fundoplication PROCEDURE

Standard surgical technique for Nissen fundoplication

Nissen fundoplication surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• \> 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);

Sponsors & Collaborators

• Implantica CE Reflux Ltd.: lead

Study Sites (4)

Universitätsklinik für Allgemeinchirurgie Klinische Abteilung für Viszeralchirurgie

Vienna, Austria

Location

St. Elisabethen Krankenhaus Frankfurt

Frankfurt, Germany

Location

Klinikum Friedrichshafen GmbH

Friedrichshafen, Germany

Location

Klinik Beau-Site Hirslanden Bern

Bern, Switzerland

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); AU (1); DE (2)