Gastroesophageal Reflux DiseaseRESTORE500NCT07004439
A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice
A study testing RefluxStop™ implantation in people with Gastroesophageal Reflux Disease, run by Implantica CE Reflux Ltd. at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- RefluxStop™ implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Sep 2025to 1 Aug 2035
- Phase
- Interventional
- 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
Who may be able to join
- Willing and able to provide informed consent and to participate in the registry study;
- Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
- Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;
- 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);
- Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.
Who cannot join
- Hiatal Hernia larger than 8 cm;
- 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
- History of bariatric surgery wherein the stomach fundus has been extirpated;
- Female subjects who are pregnant;
- Known sensitivity or allergies to silicone materials;
- Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the IFU);
- 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).
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Spain4 sites
H. La Mancha Centro
Alcázar de San Juan
Carlos Moreno, MD
H. Universitario Getafe
Getafe, Madrid
Juan Carlos Ruiz de Adana, MD
H. Infanta Sofía
Madrid
Daniel Sanchez, MD
H. Ramón y Cajal
Madrid
Julio Galindo, MD
Germany1 site
Klinikum Friedrichshafen GmbH
Friedrichshafen
Thorsten Lehmann, MD
About this study
Official title: A Post-market Registry Study Based on Standard Clinical Care to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice
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
- Being tested
- RefluxStop™ implantation
- 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 Instructions for Use
| Study group | Role | What they receive |
|---|---|---|
| Single arm: intervention | Other | Single arm registry: all enrolled patients will be implanted with RefluxStopTM Receives: Device: RefluxStop™ implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Patient Reported Outcome - Side effects (PROS)
Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline
Measured: 1 year
Secondary outcomes (2)
Incidence of safety events
Safety events include: SADEs, SAEs, ADEs, procedure-related or unknown AEs and DDs
Measured: 3 and 6 months and years 1 to 7
Reduction of Patient Reported Outcome - Side effects (PROS)
Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline
Measured: 6 months and years 2 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantica CE Reflux Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004439
- Sponsor's protocol ID
- RXI006
- Acronym
- RESTORE500
- Status last verified
- Mar 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Jun 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Registry Study Based on Standard Clinical Care to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice
- ClinicalTrials.gov ID
- NCT07004439
- Acronym / sponsor ID
- RESTORE500 / RXI006
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Implantica CE Reflux Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2035 (estimated)
- First posted
- 4 Jun 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm: intervention | Other | Device: RefluxStop™ implantationSingle arm registry: all enrolled patients will be implanted with RefluxStopTM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to provide informed consent and to participate in the registry study;
- Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
- Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;
- 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);
- Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.
Key exclusion criteria (7 listed)
- Hiatal Hernia larger than 8 cm;
- 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
- History of bariatric surgery wherein the stomach fundus has been extirpated;
- Female subjects who are pregnant;
- 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 Instructions for Use | Device | Single arm: intervention |
Primary outcome
Reduction of Patient Reported Outcome - Side effects (PROS)
Time frame: 1 year
Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline
2 secondary outcomes
Incidence of safety events
Time frame: 3 and 6 months and years 1 to 7
Reduction of Patient Reported Outcome - Side effects (PROS)
Time frame: 6 months and years 2 to 7
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 4 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RefluxStop™ implantation in people with Gastroesophageal Reflux Disease, run by Implantica CE Reflux Ltd. at 5 sites in 2 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: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Patient Reported Outcome - Side effects (PROS) (time frame: 1 year). 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 4 Jun 2025.