Gastroesophageal Reflux Disease
Conditions
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.
Interventions
DEVICERefluxStop™ implantation
Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
Sponsors
Implantica CE Reflux Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Patient Reported Outcome - Side effects (PROS) | 1 year | Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of safety events | 3 and 6 months and years 1 to 7 | Safety events include: SADEs, SAEs, ADEs, procedure-related or unknown AEs and DDs |
| Reduction of Patient Reported Outcome - Side effects (PROS) | 6 months and years 2 to 7 | Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline |
Countries
Germany, Spain
Outcome results
None listed