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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Reflux Disease (GERD)
• Intervention / Treatment: Device: RefluxStop implantation; Procedure: Nissen fundoplication

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Souheila Moutiq; Phone Number: +41 78 249 77 28; Email: souheila.moutiq@implantica.com

Study Locations

• Germany
  • Friedrichshafen, Germany, 88048
    • Active, not recruiting
    • Klinikum Friedrichshafen GmbH
• Italy
  • Bari, Italy, 70013
    • Recruiting
    • Ospedale IRCCS Saverio De Bellis
    • Contact: Leonardo Vincenti
  • Napoli, Italy, 80123
    • Recruiting
    • Ospedale Buon Consiglio Fatebenefratelli
    • Contact: Adolfo Renzi
• Norway
  • Lørenskog, Norway, 1478
    • Recruiting
    • Akershus Universitetssykehus Hf
    • Contact: Lars Eftang
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Universitätsspital Bern
    • Contact: Yves Borbély, Dr. med.
  • Bern, Switzerland, 3013
    • Recruiting
    • Hirslanden Klinik
    • Contact: Jörg Zehetner, Pr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RefluxStop patients	Device: RefluxStop implantation; Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use
Nissen fundoplication patients	Procedure: Nissen fundoplication; Standard of care Nissen fundoplication surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary safety endpoint	Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs) at 3 months and annually up to 5 years. Plus Incidence of Adverse Device Effects (ADEs) and procedure related or unknown Adverse Events (AEs) at 3 and 6 months and annually up to 5 years	3 and 6 months and annually up to 5 years
Secondary performance endpoints	Assessment of GERD symptoms, assessed by GERD-HRQL score (questions 1-10)	3 months and annually up to 5 years
Secondary performance endpoints: RefluxStop device position	Location and function of the device evaluated by a simplified contrast swallow x-ray with overview pictures of device	6 months
Secondary performance endpoints: hernia assessment	Location of baseline hernia or any new hernia by a simplified contrast swallow x-ray picture	6 months
Secondary performance endpoints: pH monitoring	Reduction or normalisation from baseline of the total acid (pH<4) exposure time during 24-hour pH monitoring	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory endpoints: Patient Reported Outcomes - Quality of life questionnaire	EQ-5D (Euro Quality of life-5 Dimension) questionnaire: measure of quality of life with one question for each of the five dimensions that are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, the patients assess if they have no problem, slight, moderate, severe or extreme problems.	3 and 6 months and annually up to 5 years
Exploratory endpoints: Patient Reported Outcomes - Work related questionnaire	WPAI (work related productivity gains): 5 questions to assess how health problems effect the patient work Score 0 to 10. Zero meaning health problems have no effect on work	3 and 6 months and annually up to 5 years
Exploratory endpoints: Health economic outcomes - Visit to General Practitioner	Evaluation of number of visit to the General Practitioner	3 and 6 months and annually up to 5 years
Exploratory endpoints: Health economic outcomes - PPI treatment use	Counting of the number of patients using PPI (Proton Pump Inhibitors)	3 and 6 months and annually up to 5 years
Exploratory endpoints: Health economic outcomes - Re-admission to hospital	Counting of the number of re-admission to hospital due to complications	3 and 6 months and annually up to 5 years
Exploratory endpoints: Health economic outcomes - Procedure costs	Evaluation of the costs related to the study procedure and the length of hospital stay	3 and 6 months and annually up to 5 years

Collaborators and Investigators

• Sponsor: Implantica CE Reflux Ltd.
• Investigators: Principal Investigator: Yves Borbély, Dr. med., Inselspital, Universitätsspital Bern

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: RXI002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No