A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice (RESTORE500)

Implantica CE Reflux

Status: Not yet enrolling

Conditions: Gastroesophageal Reflux Disease

Treatments: Device: RefluxStop™ implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07004439

RXI006

Details and patient eligibility

About

A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD.

Following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.

Enrollment: 500 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 registry study;
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 ≥ 6 months. Typical symptoms are defined as heartburn;
4. 24-hour pH or impedance 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 total time during a 24-hour monitoring) and/or total reflux episodes >55 or weekly acid >26 for > 5 seconds, all measured 5 cm above LES);
5. Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

Exclusion criteria

1. Hiatal Hernia larger than 8 cm;
2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. Patients with substantially weak peristalsis (manometry DCI value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow
3. History of bariatric surgery wherein the stomach fundus has been extirpated;
4. Female subjects who are pregnant;
5. Known sensitivity or allergies to silicone materials;
6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the IFU);
7. Subjects that are unable to comply with the registry 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Single arm: intervention

Other group

Description:

Single arm registry: all enrolled patients will be implanted with RefluxStopTM

Treatment:

Device: RefluxStop™ implantation