GERD (Gastroesophageal Reflux Disease)RENEW RCTNCT07004400
A Blinded Randomized Clinical Study of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of GERD
A study testing RefluxStop™ implantation and Nissen fundoplication in people with GERD (Gastroesophageal Reflux Disease), run by Implantica CE Reflux Ltd. at 4 sites in 3 countries.
Trial summary
This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD (Gastroesophageal Reflux Disease)
- What is being tested?
- RefluxStop™ implantation and Nissen fundoplication
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Aug 2025to 1 Dec 2026
- 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 clinical investigation;
- Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
- Documented GERD present for ≥ 12 months. Typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain;
- 24-hour 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 time during a 24-hour monitoring);
- Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator
Who cannot join
- > 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed;
- Manometry verified lack of or moderate or severe weak peristalsis in esophagus with DCI <300 or pathologic LOS function including hypercontractability, spasm or pathologic nonrelaxing functionality (the latter defined as coordinated swallows in less than 70% of wet swallows or median IRP>15mmHg). Hypercontractability defined as DCI >8'000 or pressure >45 mmHg. Thus, excluding from the study the rare diseases achalasia, scleroderma, and nutcracker esophagus, however, including mild esophageal motility disorder patients with mildly weak peristalsis;
- History of bariatric or anti-reflux surgery;
- Female subjects 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 clinical investigation procedure (as outlined in the IFU);
- Subjects that are unable to comply with the clinical investigation 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
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Germany2 sites
St. Elisabethen Krankenhaus Frankfurt
Frankfurt
Elshafei Moustafa, MD, +49 69 7939 7500, Moustafa.Elshafei@artemed.de
Klinikum Friedrichshafen GmbH
Friedrichshafen
Thorsten Lehmann., MD, + 49 7541 96 1301, Lehmann.Thorsten@medizincampus.de
Austria1 site
Universitätsklinik für Allgemeinchirurgie Klinische Abteilung für Viszeralchirurgie
Vienna
Sebastian Schoppmann, MD, +436764667340, ordination@schoppmann.at
Switzerland1 site
Klinik Beau-Site Hirslanden Bern
Bern
Jörg Zehetner, MD, +41 31 312 61 12, Joerg.Zehetner@hirslanden.ch
About this study
Official title: A Blinded Randomized Clinical Investigation of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of Gastroesophageal Reflux Disease (GERD).
This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.
Read the detailed description
This study is a post-market prospective, blinded, randomized, multicenter, multi-arm clinical investigation using standard clinical procedures to record data to evaluate the safety and performance of RefluxStop™ compared with standard Nissen fundoplication for the treatment of subjects suffering from GERD.
A randomization will be performed where the Subjects will be blinded as to assigned randomization group.
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- 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 Instructions for Use
Nissen fundoplicationProcedure or surgery
Standard surgical technique for Nissen fundoplication
| Study group | Role | What they receive |
|---|---|---|
| RefluxStop™ device implantation | Active comparator | Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use Receives: Device: RefluxStop™ implantation |
| Nissen fundoplication surgery | Active comparator | Standard surgical technique of Nissen fundoplication Receives: Procedure: Nissen fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes - Side effects (PROS) evaluation
Patient Reported Outcomes - Side effects (PROS) evaluation at 6 months, combining the well-established side effects of traditional surgical treatment methods:
- Dysphagia - swallowing difficulties;
- Odynophagia - pain at swallowing;
- Inability to belch and inability to vomit; and
- Worsening of gas bloating compared to baseline;
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 posted4 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD (Gastroesophageal Reflux Disease)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 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
- NCT07004400
- Sponsor's protocol ID
- RXI005
- Acronym
- RENEW RCT
- Status last verified
- May 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 Blinded Randomized Clinical Investigation of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of Gastroesophageal Reflux Disease (GERD).
- ClinicalTrials.gov ID
- NCT07004400
- Acronym / sponsor ID
- RENEW RCT / RXI005
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Implantica CE Reflux Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (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.
This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.
Detailed description
This study is a post-market prospective, blinded, randomized, multicenter, multi-arm clinical investigation using standard clinical procedures to record data to evaluate the safety and performance of RefluxStop™ compared with standard Nissen fundoplication for the treatment of subjects suffering from GERD.
A randomization will be performed where the Subjects will be blinded as to assigned randomization group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RefluxStop™ device implantation | Active comparator | Device: RefluxStop™ implantationStandard surgical technique for implantation RefluxStop™, as described in the Instructions for Use |
| Nissen fundoplication surgery | Active comparator | Procedure: Nissen fundoplicationStandard surgical technique of Nissen fundoplication |
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 clinical investigation;
- Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
- Documented GERD present for ≥ 12 months. Typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain;
- 24-hour 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 time during a 24-hour monitoring);
- Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator
Key exclusion criteria (7 listed)
- > 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed;
- Manometry verified lack of or moderate or severe weak peristalsis in esophagus with DCI <300 or pathologic LOS function including hypercontractability, spasm or pathologic nonrelaxing functionality (the latter defined as coordinated swallows in less than 70% of wet swallows or median IRP>15mmHg). Hypercontractability defined as DCI >8'000 or pressure >45 mmHg. Thus, excluding from the study the rare diseases achalasia, scleroderma, and nutcracker esophagus, however, including mild esophageal motility disorder patients with mildly weak peristalsis;
- History of bariatric or anti-reflux surgery;
- Female subjects 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 Instructions for Use | Device | RefluxStop™ device implantation |
| Nissen fundoplicationStandard surgical technique for Nissen fundoplication | Procedure or surgery | Nissen fundoplication surgery |
Primary outcome
Patient Reported Outcomes - Side effects (PROS) evaluation
Time frame: 6 months
Patient Reported Outcomes - Side effects (PROS) evaluation at 6 months, combining the well-established side effects of traditional surgical treatment methods: * Dysphagia - swallowing difficulties; * Odynophagia - pain at swallowing; * Inability to belch and inability to vomit; and * Worsening of gas bloating compared to baseline;
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.
Universitätsklinik für Allgemeinchirurgie Klinische Abteilung für Viszeralchirurgie
Vienna, Austria
Klinikum Friedrichshafen GmbH
Friedrichshafen, Germany
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RefluxStop™ implantation and Nissen fundoplication in people with GERD (Gastroesophageal Reflux Disease), run by Implantica CE Reflux Ltd. at 4 sites in 3 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 4 sites in Germany, Austria, Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes - Side effects (PROS) evaluation (time frame: 6 months). 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.