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ClinicalTrials.gov ID

NCT07004400

Lead Sponsor

Implantica CE Reflux Ltd.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

Jun 4, 2025Actual

Start Date

Aug 1, 2025Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

Official Title

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

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.

• GERD (Gastroesophageal Reflux Disease)

• RefluxStop™ implantation
• Nissen fundoplication

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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);

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Implantica CE Reflux Ltd.INDUSTRY

Moustafa.Elshafei@artemed.de+49 69 7939 7500

Lehmann.Thorsten@medizincampus.de+ 49 7541 96 1301

Joerg.Zehetner@hirslanden.ch+41 31 312 61 12