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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P250018 / PAS001 |
| Date Original Protocol Accepted |
08/20/2026
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| Date Current Protocol Accepted |
08/20/2026
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| Study Name |
REVEAL New Enrollment Study
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| Device Name |
RefluxStop® Device and RefluxStop® Deployment Tool
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
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| Study Population |
Transit.Adolescent A (distinctively):18 yrs<22 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objective of the study is to evaluate the long-term safety and effectiveness of the RefluxStop device in the treatment of Gastroesophageal Reflux Disease (GERD). The study is a single-arm, prospective, multi-center, new-enrollment clinical study.
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| Study Population |
Patients greater than or equal to 18 years old with hiatal hernia size < 3 cm who are diagnosed with acid or non-acid Gastroesophageal Reflux Disease (GERD) who meet the following criteria:
- Documented GERD present for > 6 months
- Patient has endoscopy verified esophagitis, and/or a 24-hour pH monitoring proven GERD defined as pathologic number of impedance pH reflux episodes of acid or weakly acid and/or pathologic pH <4 for >4.5% of the total time, off PPI therapy for at least 7 days prior to testing.
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| Sample Size |
200 patients will be enrolled at 4-10 sites, with at least 50 % of sites located in the United States and at least half of all RefluxStop procedures performed at U.S. sites.
With an expected 12% dropout rate over 5 years, 176 patients will be available for analysis of 5-year endpoints. A 6% dropout rate is expected at 1 year. The study is expected to detect any side effects/ adverse
events with high probability even if they are uncommon. For example, an event that occurs in 1 per 100 patients will be detected with a probability of 83% and an event that occurs with a frequency of 1 per 50 patients will be detected with a probability of 97%. Thus, with this sample size, all events that are common and events that are uncommon will be detected with a high probability.
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| Key Study Endpoints |
Primary Safety Endpoint: Incidence of procedure and device related serious adverse device effects (SADEs), serious adverse events (SAEs) and device deficiencies (DDs) at 1 year post RefluxStop implant.
Primary Effectiveness Endpoint: Pathologic acid in the lower esophagus measured by 24-hour pH monitoring (total percentage of time pH <4) at 1 year post RefluxStop implant.
Secondary Safety Endpoints:
- Incidence of procedure- and device-related SADEs, SAEs and DDs at all time points excluding at year 1, comprising month 6 as well as years 2 to 5
- Incidence of procedure- or device-related Adverse Events (ADEs or AEs) at 6 months and annually thereafter up to 5 years
Secondary Effectiveness Endpoints:
- Subjects with <50% improvement of GERD-HRQL at year 1 compared to baseline
- Reduction in GERD-HRQL group score, measured at 6 months and years 1 to 5 compared to baseline
- Regular daily PPI usage Due to GERD/acid reflux, with PPI question completed at 6 months and years 1 to 5
(Note: Requirement of at least one episode of terminating the PPI medication for at least 6 weeks at a time point after the 6-month visit. If subject uses PPI at or after the 2-year visit, one more period of PPI drug termination should occur at a time point as of the 2-year follow-up.)
- Total percentage of time pH <4 measured by 24-hour pH monitoring at year 1 (mean and standard deviation on group level)
- Pathologic 24-hour pH monitoring and on-label device position at year 2-5
- Incidence of inability to belch based on questionnaire at 6 months and annually at years 1 to 5
Other Endpoints:
- Contrast swallow x-ray as a surgical control at hospital stay (gastrographin only at hospital stay) and 5 years visit (barium), and in “Subjects with possible acid reflux” (regular daily PPI usage or GERD-HRQL score <50% improved from baseline) which occurs after the year 1 visit (performed once only using barium)
Note: The TSC analyzes the surgical procedure and the categorization of the device position to determine Failure risk or Unacceptable as determined by the contrast swallow x-ray of all “subjects with possible acid reflux.” Failure subjects having acid reflux caused by a placement that is too low or too far from esophagus are controlled.
- Regurgitation frequency question (episodes per day or week) at 6 months and annually at years 1 to 5
- Functional Lumen Imaging Probe (FLIP) assessment may be performed at the discretion of the Investigator in subjects with persistent dysphagia after 6 months follow-up
- In patients with severe gastric emptying problems based on anamnesis, an emptying test may be performed, either gastric emptying scintigraphy or stable isotope breath test may be used
- Grade of esophagitis (Grade A, Grade B, Grade C, Grade D) from esophago-gastroduodenoscopy (EGD) at baseline and year 1
- Number of subjects reporting AE = ‘Gastritis’
- New GERD-HRQL and 24-h pH monitoring should be carried out 6 months after any re-surgery has been performed
- Patient dissatisfaction due to GERD
- Procedure-related operational complications
- Length of patients’ hospital stay and length of surgery
- Manometry data
- Failure indication: Subjects with both objective and subjective indication of potential therapy failure. Indications of therapy failure are pathologic 24-hour pH monitoring, consuming regular daily PPI due to GERD and being dissatisfied due to GERD.
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