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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870163
• Other study ID #: RXI002
• Status: Recruiting
• Start date: February 20, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2023
• Source: Implantica CE Reflux Ltd.
• Contact: Souheila Moutiq
• Phone: +41 78 249 77 28
• Email: souheila.moutiq[@]implantica.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2029
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

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

Procedure:
• Nissen fundoplication
Standard of care Nissen fundoplication surgery

Locations

Country	Name	City	State
Germany	Mathilden Hospital	Herford
Switzerland	Hirslanden Klinik	Bern
Switzerland	Inselspital, Universitätsspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Implantica CE Reflux Ltd.

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Primary safety endpoint	Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs)	6 months
Primary	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	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	Secondary performance endpoints	Assessment of GERD symptoms, assessed by GERD-HRQL score (questions 1-10)	3 months and annually up to 5 years
Secondary	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	Secondary performance endpoints: hernia assessment	Location of baseline hernia or any new hernia by a simplified contrast swallow x-ray picture	6 months
Secondary	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