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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT04834635
Eligibility Criteria:
Inclusion Criteria:
* BMI from 30 to 50 kg / m2.
* The person is generally fit for anesthesia (ASA grading 1-2) and surgery.
* The person commits to the need for long-term follow-up.
Exclusion Criteria:
* BMI less than 30 kg / m2 and more than 50 kg / m2.
* Prosthetic (mesh) Hiatal herniorrhaphy or large hiatal hernia;
* Esophageal shortening
* Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis
* History of surgery on the stomach or esophagus
* Less than 18 or more than 60 years of age
* Not fit for bariatric surgery
* Psychiatric illness
* Patients unwilling or unable to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04834635
Study Brief:
Protocol Section:
NCT04834635