Actively Recruiting
Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
Led by Implantica CE Reflux Ltd. · Updated on 2025-04-01
2500
Participants Needed
6
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent and participate in the study
- Age 18 years or older (or according to local legal age of adulthood)
- Documented diagnosis of GERD lasting more than 6 months
- 24-hour pH monitoring confirming GERD with specific acid or reflux episode measurements, off PPI therapy for at least 7 days prior to testing
- Suitable for general anesthesia and laparoscopic surgery as determined by the investigator
You will not qualify if you...
- Presence of para-esophageal hernia or sliding hernia larger than 3 centimeters
- Known delayed gastric emptying without another cause for acid reflux
- History of bariatric surgery removing the stomach fundus
- Pregnant or nursing female patients
- Known allergy or sensitivity to silicone materials
- Intraoperative findings that prevent proper conduct of the study procedure
- Inability to comply with study requirements due to major psychiatric disorder or other investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Klinikum Friedrichshafen GmbH
Friedrichshafen, Germany, 88048
Active, Not Recruiting
2
Ospedale IRCCS Saverio De Bellis
Bari, Italy, 70013
Actively Recruiting
3
Ospedale Buon Consiglio Fatebenefratelli
Naples, Italy, 80123
Actively Recruiting
4
Akershus Universitetssykehus HF
Lørenskog, Norway, 1478
Actively Recruiting
5
Inselspital, Universitätsspital Bern
Bern, Switzerland, 3010
Actively Recruiting
6
Hirslanden Klinik
Bern, Switzerland, 3013
Actively Recruiting
Research Team
S
Souheila Moutiq
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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