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

Implantica CE Reflux

Status: Not yet enrolling

Conditions: GERD (Gastroesophageal Reflux Disease)

Treatments: Procedure: Nissen fundoplication; Device: RefluxStop™ implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07004400

RXI005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

RefluxStop™ device implantation

Active Comparator group

Description:

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

Treatment:

Device: RefluxStop™ implantation

Nissen fundoplication surgery

Active Comparator group

Description:

Standard surgical technique of Nissen fundoplication

Treatment:

Procedure: Nissen fundoplication