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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT04763993
Eligibility Criteria:
Inclusion Criteria:
* Acceptance of randomization to surgery;
* Participant is willing and able to give informed consent for participation in the trial;
* Written informed consent;
* Compliance to follow-up;
* Male and female;
* ≥18 and ≤70 years old;
* BMI ≥ 35 with obesity-related comorbidities;
* BMI ≥ 40 with or without obesity-related comorbidities;
* GERDQ score ≥ 3 points;
* Use of proton pump inhibitor;
* Mild and Moderate GERD (DMS ≥14.72 ≤100)
* Incompetence of the Esophagogastric junction
* Los Angeles grade A, B, C, D esophagitis.
Exclusion criteria
* Medical or psychiatric conditions that compromises the patient's ability to give informed consent or comply with the study protocol;
* Barrett's esophagus (BE);
* Spastic motor disorders and esophageal hypomotility;
* Peptic strictures;
* Absence of GERD (DMS\<14.72);
* Severe GERD (DMS\>100);
* Hiatal hernia \> 5 cm;
* Previous bariatric surgery or major general surgery;
* Type 2 diabetes (T2D) for more than \> 5 years;
* Necessity to explore stomach, the duodenum or the biliary tract;
* Refuse of randomization;
* Personal reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04763993
Study Brief:
Protocol Section:
NCT04763993