Gastroesophageal Reflux Disease (GERD)NCT05870163
Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
An observational study of Gastroesophageal Reflux Disease (GERD), run by Implantica CE Reflux Ltd. at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- RefluxStop implantation and Nissen fundoplication
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 2,500 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 20 Feb 2023to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RefluxStop device and Nissen fundoplication are indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) defined by abnormal pH testing.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Italy2 sites, 2 recruiting
- Recruiting
Ospedale IRCCS Saverio De Bellis
Bari, 70013
Leonardo Vincenti
- Recruiting
Ospedale Buon Consiglio Fatebenefratelli
Naples, 80123
Adolfo Renzi
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital, Universitätsspital Bern
Bern, 3010
Yves Borbély, Dr. med.
- Recruiting
Hirslanden Klinik
Bern, 3013
Jörg Zehetner, Pr.
Germany1 site
- Active, not recruiting
Klinikum Friedrichshafen GmbH
Friedrichshafen, 88048
Norway1 site, 1 recruiting
- Recruiting
Akershus Universitetssykehus HF
Lørenskog, 1478
Lars Eftang
About this study
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
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)
- Being tested
- RefluxStop implantation, Nissen fundoplication
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RefluxStop implantationDevice
Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use
Nissen fundoplicationProcedure or surgery
Standard of care Nissen fundoplication surgery
| Study group | Role | What they receive |
|---|---|---|
| RefluxStop patients | Not described Receives: Device: RefluxStop implantation | |
| Nissen fundoplication patients | Not described Receives: Procedure: Nissen fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint
Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs)
Measured: 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)
Measured: 6 months
Secondary outcomes (5)
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
Measured: 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)
Measured: 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
Measured: 6 months
Secondary performance endpoints: hernia assessment
Location of baseline hernia or any new hernia by a simplified contrast swallow x-ray picture
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start20 Feb 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Implantica CE Reflux Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Borbély, Dr. med., Principal investigator, Inselspital, Universitätsspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870163
- Sponsor's protocol ID
- RXI002
- Status last verified
- Mar 2025
- First submitted
- 14 Apr 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05870163
- Acronym / sponsor ID
- RXI002
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Implantica CE Reflux Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RefluxStop patients | – | Device: RefluxStop implantation |
| Nissen fundoplication patients | – | Procedure: Nissen fundoplication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RefluxStop device and Nissen fundoplication are indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) defined by abnormal pH testing.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RefluxStop implantationStandard surgical technique for implantation RefluxStop, as described in the Itructions for Use | Device | RefluxStop patients |
| Nissen fundoplicationStandard of care Nissen fundoplication surgery | Procedure or surgery | Nissen fundoplication patients |
Primary outcome
Primary safety endpoint
Time frame: 6 months
Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs)
Primary performance endpoint
Time frame: 6 months
Assessment of GERD symptoms, measured by GERD Health-Related Quality of Life (HRQL) score (questions 1-10). (An answer of zero means no symptoms)
5 secondary outcomes
Secondary safety endpoint
Time frame: 3 and 6 months and annually up to 5 years
Secondary performance endpoints
Time frame: 3 months and annually up to 5 years
Secondary performance endpoints: RefluxStop device position
Time frame: 6 months
Secondary performance endpoints: hernia assessment
Time frame: 6 months
Secondary performance endpoints: pH monitoring
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yves Borbély, Dr. med. principal investigator
Inselspital, Universitätsspital Bern
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD), run by Implantica CE Reflux Ltd. at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Switzerland, Germany, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Souheila Moutiq (+41 78 249 77 28, souheila.moutiq@implantica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.