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

NCT ID: NCT07004439

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2035-08-01

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm: intervention

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

Group Type: OTHER

RefluxStop™ implantation

Intervention Type: DEVICE

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

Interventions

RefluxStop™ implantation

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• 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

Klinikum Friedrichshafen GmbH

Friedrichshafen, , Germany

H. Universitario Getafe

Getafe, Madrid, Spain

H. La Mancha Centro

Alcázar de San Juan, , Spain

H. Infanta Sofía

Madrid, , Spain

H. Ramón y Cajal

Madrid, , Spain

Countries

Germany; Spain

Facility Contacts

Thorsten Lehmann, MD

Role: primary

Juan Carlos Ruiz de Adana, MD

Role: primary

Carlos Moreno, MD

Role: primary

Daniel Sanchez, MD

Role: primary

Julio Galindo, MD

Role: primary

Other Identifiers

RXI006

Identifier Type: -

Identifier Source: org_study_id