Trials / Recruiting
RecruitingNCT05870163
Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
A Post-market Registry Study to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,500 (estimated)
- Sponsor
- Implantica CE Reflux Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-02-20
- Primary completion
- 2025-12-01
- Completion
- 2029-12-31
- First posted
- 2023-05-23
- Last updated
- 2025-04-01
Locations
6 sites across 4 countries: Germany, Italy, Norway, Switzerland
Source: ClinicalTrials.gov record NCT05870163. Inclusion in this directory is not an endorsement.