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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT01026103
Eligibility Criteria:
Inclusion Criteria:
* The patient must be 18-65 years of age.
* The patient has a BMI of 40-60 kg/m2, or 35-40 kg/m2 with one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass.
* The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.
Exclusion Criteria:
* The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
* The patient is pregnant.
* The patient has an active or history of, infection at the operative site.
* The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
* Patient has an abdominal ventral hernia requiring mesh repair
* The patient has a history of clinically significant liver disease
* The patient has a history of drug or alcohol abuse within 2 years of enrollment
* The patient has a history of venous thrombosis or pulmonary embolism
* The patient has a history of coagulopathy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01026103
Study Brief:
Protocol Section:
NCT01026103