Clinical trial NCT07004439: A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice
Official title: A Post-market Registry Study Based on Standard Clinical Care to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Implantica CE Reflux Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD.

Following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide informed consent and to participate in the registry study;
2. Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
3. Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;
4. 24-hour pH or impedance 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 total time during a 24-hour monitoring) and/or total reflux episodes \>55 or weekly acid \>26 for \> 5 seconds, all measured 5 cm above LES);
5. Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

Exclusion Criteria:

1. Hiatal Hernia larger than 8 cm;
2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. Patients with substantially weak peristalsis (manometry DCI value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow
3. History of bariatric surgery wherein the stomach fundus has been extirpated;
4. Female subjects who are pregnant;
5. Known sensitivity or allergies to silicone materials;
6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the IFU);
7. Subjects that are unable to comply with the registry 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).

Primary outcomes:
measure: Reduction of Patient Reported Outcome - Side effects (PROS)
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of safety events
timeFrame: 3 and 6 months and years 1 to 7
measure: Reduction of Patient Reported Outcome - Side effects (PROS)
timeFrame: 6 months and years 2 to 7
Other outcomes:
Locations:
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen GmbH
city: Getafe
country: Spain
facility: H. Universitario Getafe
state: Madrid
city: Alcazar de San Juan
country: Spain
facility: H. La Mancha Centro
city: Madrid
country: Spain
facility: H. Infanta Sofía
city: Madrid
country: Spain
facility: H. Ramón y Cajal
Study officials:
References: