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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01232959
Eligibility Criteria:
Inclusion criteria
* Female patients undergoing elective cholecystectomy for cholelithiasis.
Exclusion criteria
* Male patients, patients \<18 years or \>65 years of age
* Pregnant patients
* Patients with prior pelvic surgery
* Patients with prior hepatobiliary surgery or other major abdominal surgery
* Patients with ASA class \>3
* Patients with BMI \>35
* Patients with risk factors for requiring an open cholecystectomy (e.g. possible gallbladder cancer, acute cholecystitis, jaundice)
* Patients who cannot provide consent for the study
* Patients not willing to participate in the study.
* Patients with common bile duct stones
* Patients with evidence of abdominal abscess or mass
* Patients with diffuse peritonitis
* Patients with a clinical diagnosis of sepsis
* Patients with coagulopathy or using anticoagulants or anti-platelet agents (aspirin up to 81mg/day acceptable)
* Patients with planned concurrent procedures
* Patients with a prior diagnosis of intra-abdominal adhesions
* Patients who are participating in any other investigational device or drug trial that has not yet completed the primary endpoint
* Patients with an enlarged uterus
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01232959
Study Brief:
Protocol Section:
NCT01232959