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

NCT05870163 | Recruiting DMC

• 1 other identifier: RXI002
• Study Type: observational
• Target: 2,500
• Locations: 4 countries
• Sites: 6

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease (GERD)

Outcome Measures

Primary Outcomes (2)

• Primary safety endpoint

  Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs)

  6 months

• Primary performance endpoint

  Assessment of GERD symptoms, measured by GERD Health-Related Quality of Life (HRQL) score (questions 1-10). (An answer of zero means no symptoms)

  6 months

Secondary Outcomes (5)

• Secondary safety endpoint

  3 and 6 months and annually up to 5 years

• Secondary performance endpoints

  3 months and annually up to 5 years

• Secondary performance endpoints: RefluxStop device position

  6 months

• Secondary performance endpoints: hernia assessment

  6 months

• Secondary performance endpoints: pH monitoring

  6 months

Other Outcomes (6)

• Exploratory endpoints: Patient Reported Outcomes - Quality of life questionnaire

  3 and 6 months and annually up to 5 years

• Exploratory endpoints: Patient Reported Outcomes - Work related questionnaire

  3 and 6 months and annually up to 5 years

• Exploratory endpoints: Health economic outcomes - Visit to General Practitioner

  3 and 6 months and annually up to 5 years

Study Arms (2)

RefluxStop patients

Device: RefluxStop implantation

Nissen fundoplication patients

Procedure: Nissen fundoplication

Interventions

RefluxStop implantation DEVICE

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

RefluxStop patients

Nissen fundoplication PROCEDURE

Standard of care Nissen fundoplication surgery

Nissen fundoplication patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

RefluxStop device and Nissen fundoplication are indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) defined by abnormal pH testing.

You may qualify if:

• Willing and able to provide informed consent and to participate in the registry study,
• Patient's age ≥ 18 years or according to local legal age of adulthood if older,
• Documented GERD present for \> 6 months,
• 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)
• Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

You may not qualify if:

• Presence of para-esophageal hernia or sliding hernia \> 3 centimeters,
• Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
• History of bariatric surgery wherein the stomach fundus has been extirpated,
• Female patients who are pregnant or nursing,
• Known sensitivity or allergies to silicone materials,
• Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU);
• 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).

Sponsors & Collaborators

• Implantica CE Reflux Ltd.: lead

Study Sites (6)

Klinikum Friedrichshafen GmbH

Friedrichshafen, 88048, Germany

ACTIVE NOT RECRUITING

Ospedale IRCCS Saverio De Bellis

Bari, 70013, Italy

RECRUITING

Ospedale Buon Consiglio Fatebenefratelli

Napoli, 80123, Italy

RECRUITING

Akershus Universitetssykehus HF

Lørenskog, 1478, Norway

RECRUITING

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

RECRUITING

Hirslanden Klinik

Bern, 3013, Switzerland

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yves Borbély, Dr. med.

  Inselspital, Universitätsspital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Souheila Moutiq

CONTACT

+41 78 249 77 28; souheila.moutiq@implantica.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 23, 2023
• Study Start: February 20, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NO (1); IT (2); CH (2)