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 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT05711758
Eligibility Criteria:
Inclusion Criteria:
* subjects must be 18-70 years of age
* eligible for endoscopic and surgical weight loss procedures
* body mass index (BMI) greater than 35 kg/m2
* Individuals must be in excellent mental health
* able to understand and sign informed consent
* available to return for all routine follow-up study visits
Exclusion Criteria:
* untreated H. pylori infection
* gastroparesis
* active smoking
* an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
* previous pyloromyotomy or pyloroplasty
* gastrointestinal obstruction
* severe coagulopathy
* esophageal or gastric varices and/or portal hypertensive gastropathy
* pregnancy or puerperium
* any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)
* malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)
* severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)
* lactation
* history of gastrointestinal surgery
* any serious health condition unrelated to their weight that would increase the risk of endoscopy
* chronic abdominal pain
* active psychological issues preventing participation in a lifestyle modification program
* a known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
* an inability to provide informed consent
* use of any medication that may interfere with weight loss
* use of any medication that may interfere with gastric emptying
* any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05711758
Study Brief:
Protocol Section:
NCT05711758