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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07344935
Eligibility Criteria:
Inclusion Criteria
* Body Mass Index (BMI) ≥ 30 kg/m² (or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity, e.g., type 2 diabetes, hypertension, dyslipidemia).
* Medically eligible for laparoscopic sleeve gastrectomy (LSG) or Nissan sleeve surgery, as determined by a multidisciplinary bariatric team (e.g., surgeon, endocrinologist, dietitian).
* Ability to understand and voluntarily sign written informed consent.
* Willingness to comply with post-operative follow-up protocols (e.g., dietary monitoring, clinical visits, laboratory tests).
Exclusion Criteria
* BMI \< 30 kg/m² (or \< 27 kg/m² without obesity-related comorbidities).
* Contraindications to laparoscopic surgery (e.g., severe abdominal adhesions, hemodynamic instability, uncorrected coagulopathy).
* History of major gastrointestinal surgery (e.g., gastric bypass, colectomy) or anatomical abnormalities precluding sleeve gastrectomy.
* Active or uncontrolled chronic diseases (e.g., end-stage renal disease, cirrhosis, metastatic cancer, severe cardiovascular disease).
* Psychiatric disorders limiting adherence to post-operative care (e.g., severe depression, psychosis, substance use disorder).
* Pregnancy or breastfeeding (or plans for pregnancy within 12 months post-surgery).
* Allergy or intolerance to surgical materials, anesthesia, or post-operative medications required for the study.
* Inability to communicate or cooperate with study procedures (e.g., language barriers, cognitive impairment).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07344935
Study Brief:
Protocol Section:
NCT07344935