Clinical trial NCT05870163: Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
Official title: A Post-market Registry Study to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroesophageal Reflux Disease (GERD)
Lead sponsor: Implantica CE Reflux Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RefluxStop device and Nissen fundoplication are indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) defined by abnormal pH testing.

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide informed consent and to participate in the registry study,
2. Patient's age ≥ 18 years or according to local legal age of adulthood if older,
3. Documented GERD present for \> 6 months,
4. Patient has a 24-hour pH monitoring proven GERD with pH and/or impedance 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 and/or total reflux episodes of acid \>55 or weakly acid \>26 for \>5 seconds at 5 cm above LES)
5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

Exclusion criteria:

1. Presence of para-esophageal hernia or sliding hernia \> 3 centimeters,
2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
3. History of bariatric surgery wherein the stomach fundus has been extirpated,
4. Female patients who are pregnant or nursing,
5. Known sensitivity or allergies to silicone materials,
6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU);
7. Patients that are unable to comply with the registry study requirements, (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the registry study according to the investigator's judgement).

Primary outcomes:
measure: Primary safety endpoint
timeFrame: 6 months
measure: Primary performance endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Secondary safety endpoint
timeFrame: 3 and 6 months and annually up to 5 years
measure: Secondary performance endpoints
timeFrame: 3 months and annually up to 5 years
measure: Secondary performance endpoints: RefluxStop device position
timeFrame: 6 months
measure: Secondary performance endpoints: hernia assessment
timeFrame: 6 months
measure: Secondary performance endpoints: pH monitoring
timeFrame: 6 months
Other outcomes:
measure: Exploratory endpoints: Patient Reported Outcomes - Quality of life questionnaire
timeFrame: 3 and 6 months and annually up to 5 years
measure: Exploratory endpoints: Patient Reported Outcomes - Work related questionnaire
timeFrame: 3 and 6 months and annually up to 5 years
measure: Exploratory endpoints: Health economic outcomes - Visit to General Practitioner
timeFrame: 3 and 6 months and annually up to 5 years
measure: Exploratory endpoints: Health economic outcomes - PPI treatment use
timeFrame: 3 and 6 months and annually up to 5 years
measure: Exploratory endpoints: Health economic outcomes - Re-admission to hospital
timeFrame: 3 and 6 months and annually up to 5 years
measure: Exploratory endpoints: Health economic outcomes - Procedure costs
timeFrame: 3 and 6 months and annually up to 5 years
Locations:
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen GmbH
city: Bari
country: Italy
facility: Ospedale IRCCS Saverio De Bellis
city: Napoli
country: Italy
facility: Ospedale Buon Consiglio Fatebenefratelli
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus HF
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
city: Bern
country: Switzerland
facility: Hirslanden Klinik
Study officials:
affiliation: Inselspital, Universitätsspital Bern
name: Yves Borbély, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: