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:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT07093359
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years and above
2. Willing and able to give informed consent
3. Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery
4. Symptomatic and objectively defined GORD; endoscopy with appearances or biopsies consistent with reflux oesophagitis, or 24-hour pH study or BRAVO test of the oesophagus consistent with GORD
5. No hiatal hernia or hiatal hernia \<5 cm in length
6. Adequate lower oesophageal motility as defined by preoperative oesophageal manometry study. Oesophageal manometry will show a mean contractile amplitude of \>30 mmHg or DCI \>450 mmHg-s-cm in 70% of swallows.
Exclusion Criteria:
1. Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia
2. Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials
3. Previous anti-reflux or gastric surgery
4. Previous or planned neurosurgical intervention
5. Oesophageal manometry showing complete absence of lower oesophageal contractility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07093359
Study Brief:
Protocol Section:
NCT07093359