Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02759094
Eligibility Criteria:
Inclusion Criteria:
* Subject's age \>= 18 years and \<= 75 years
* Subject is able to undergo general anaesthesia and is a suitable laparoscopic surgical candidate
* Subject is willing and able to participate
* Subject has provided written informed consent after being informed of the study procedure and risks prior to any study-related events
* Subject has documented typical GERD symptoms present for \> 6 months which respond to PPIs as anti-GERD medication. Typical symptom of GERD is defined as heartburn, which is a burning epigastric or substernal pain
* Subject requires daily PPI anti GERD medication
* Subject has a 24-hour pH monitoring proven GERD performed taken off any anti reflux medication or after discontinuation for at least 7 days prior to testing. Total distal esophageal pH must be \<= 4 for \>= 4.5% if time during a 24-hour monitoring
Exclusion Criteria:
* Subject is currently participating in another study involving investigational drugs or devices
* Subject has a history of gastro esophageal surgery, anti-reflux or bariatric procedure
* Subject has a history of endoscopic anti-reflux intervention
* Subject has a history or a suspicion of esophageal or gastric cancer
* Subject has a history of major psychiatric disorder
* Presence of a para-esophageal hernia or sliding hernia of \> 3cm determined on endoscopy
* Presence of an esophagitis grade C or D according to the Los Angeles classification
* Presence of esophageal dysmotility disorder such as but not limited to scleroderma, achalasia, Nutcracker oesophagus
* Presence of esophageal stricture or stenosis
* Presence of delayed gastric emptying
* Presence of esophageal or gastric varies
* Subject has a body mass index (BMI) \> 35kg/m2
* Female subjects who are pregnant or nursing
* Known sensitivity or allergies to silicone materials
* Subjects who are unable to comply with the protocol requirements
* Subjects with limited life expectancy (\< 3 years)
* Intra-operative findings that may preclude conduct of the study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02759094
Study Brief:
Protocol Section:
NCT02759094