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

NCT ID: NCT07004400

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-01

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.

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.

Conditions

GERD (Gastroesophageal Reflux Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RefluxStop™ device implantation

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

Group Type: ACTIVE_COMPARATOR

RefluxStop™ implantation

Intervention Type: DEVICE

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

Nissen fundoplication surgery

Standard surgical technique of Nissen fundoplication

Group Type: ACTIVE_COMPARATOR

Nissen fundoplication

Intervention Type: PROCEDURE

Standard surgical technique for Nissen fundoplication

Interventions

RefluxStop™ implantation

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

Intervention Type: DEVICE

Nissen fundoplication

Standard surgical technique for Nissen fundoplication

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Willing and able to provide informed consent and to participate in the clinical investigation;

2. Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;

3. Documented GERD present for ≥ 12 months. Typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain;

4. 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);

5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator

Exclusion Criteria

1. > 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed;

2. 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;

3. History of bariatric or anti-reflux surgery;

4. Female subjects who are pregnant or nursing;

5. Known sensitivity or allergies to silicone materials;

6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the clinical investigation procedure (as outlined in the IFU);

7. 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);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Implantica CE Reflux Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik für Allgemeinchirurgie Klinische Abteilung für Viszeralchirurgie

Vienna, , Austria

St. Elisabethen Krankenhaus Frankfurt

Frankfurt, , Germany

Klinikum Friedrichshafen GmbH

Friedrichshafen, , Germany

Klinik Beau-Site Hirslanden Bern

Bern, , Switzerland

Countries

Austria; Germany; Switzerland

Facility Contacts

Sebastian Schoppmann, MD

Role: primary

ordination@schoppmann.at

+436764667340

Elshafei Moustafa, MD

Role: primary

Moustafa.Elshafei@artemed.de

+49 69 7939 7500

Thorsten Lehmann., MD

Role: primary

Lehmann.Thorsten@medizincampus.de

+ 49 7541 96 1301

Jörg Zehetner, MD

Role: primary

Joerg.Zehetner@hirslanden.ch

+41 31 312 61 12

Other Identifiers

RXI005

Identifier Type: -

Identifier Source: org_study_id