Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment

Implantica CE Reflux

Status: Enrolling

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Procedure: Nissen fundoplication; Device: RefluxStop implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT05870163

RXI002

Details and patient eligibility

About

This post-market registry aims to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in standard of care procedures.

Enrollment: 2,500 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. Patient's age ≥ 18 years or according to local legal age of adulthood if older,
3. Documented GERD present for > 6 months,
4. Patient has a 24-hour pH monitoring proven GERD with pH and/or impedance 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 and/or total reflux episodes of acid >55 or weakly acid >26 for >5 seconds at 5 cm above LES)
5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

Exclusion criteria

1. Presence of para-esophageal hernia or sliding hernia > 3 centimeters,
2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
3. History of bariatric surgery wherein the stomach fundus has been extirpated,
4. Female patients 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 registry study procedure (as outlined in the IFU);
7. Patients that are unable to comply with the registry study requirements, (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the registry study according to the investigator's judgement).

Trial design

2,500 participants in 2 patient groups

RefluxStop patients

Treatment:

Device: RefluxStop implantation

Nissen fundoplication patients

Treatment:

Procedure: Nissen fundoplication