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:
NCT05775133
Eligibility Criteria:
Inclusion Criteria
* All patients age \> 18 years old who are planned for elective laparoscopic cholecystectomy; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent.
* Eligible patients will be screened and assigned as per risk calculator for difficulty of LC
* Diagnosis:
* All patients with clinical suspicion and diagnosis of symptomatic cholelithiasis or cholecystitis planned for cholecystectomy.
* Typical imaging as per standard workup findings including US, CT and/or MRI. Plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis.
* Prior therapy:
o Patients with prior surgery are eligible for enrollment.
* Laboratory:
* Hemoglobin \> 9 g/dL
* Platelet count ≥75,000/µL (may receive transfusions)
* Normal prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) \< 1.5 x upper limit of normal (including patients on prophylactic anticoagulation)
* Liver Function Test
* Renal function: Age-adjusted normal serum creatinine
* Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry \>94% on room air if there is any clinical indication for determination.
Exclusion Criteria
* Non-elective acute cholecystectomy will be excluded.
* Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, and pregnancy.
* Patients eligible for cholecystectomy, exclusion criteria include known allergy to ICG; coagulopathy or known, pre-existing liver disease; pregnancy or breast-feeding; or being of reproductive age with pregnancy possible and not ruled out.
* Patients currently in any investigational agents.
* Adults unable to consent
* Individuals under 18 years of age
* Pregnant women
* Prisoners
* Vulnerable populations
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05775133
Study Brief:
Protocol Section:
NCT05775133