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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05243433
Eligibility Criteria:
Inclusion Criteria:
* Age: ≥ 18 to ≤ 75 years
* Scheduled for one of the following non-emergent laparoscopic procedure: cholecystectomy, hernia repair, appendectomy, bariatric surgery (gastric sleeve or gastric bypass), or colectomy.
* Willing to comply with protocol-specified follow-up evaluation
* Signed informed consent
Exclusion Criteria:
* Advanced refusal of blood transfusion, if necessary;
* Active systemic or cutaneous infection or inflammation;
* Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
* Uncontrolled diabetes mellitus;
* Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count \< 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
* Severe co-existing morbidities having a life expectancy of less than 30 days;
* Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study;
* Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
* Renal insufficiency (serum creatinine of \> 2.5 mg/dl);
* Females who are pregnant, planning to become pregnant within three months of the procedure, or lactating;
* Extreme morbid obesity (BMI greater than 45 kg/m2);
* Patients presenting with ascites;
* Patients presenting for emergency surgery;
* Previous surgery in the same anatomical location;
* Lack of capacity to give informed consent (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05243433
Study Brief:
Protocol Section:
NCT05243433