Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fox Chase Cancer Center
With
Mauna Kea Technologies
Johnson & Johnson
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.
Patients undergoing robotic navigational bronchoscopy for evaluation of indeterminate lung nodules with largest dimension size of 8-30 mm
Age \> 18 years.
Patients must have normal organ and marrow functions as defined below:
Leukocytes \> 3,000/mcL Absolute neutrophil count \> 1,500/mcL Total bilirubin within normal institutional limits Hemoglobin ≥7.0 AST/ALT (SGOT/SGPT) \< 2 times institutional normal limits Creatinine OR Creatinine Clearance within normal institutional limits OR \> 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal
Ability to understand and willingness to sign a written informed consent and HIPAA consent document
WOCBP must agree not to get pregnant until after the day of the procedure
You may not be if
Patients with uncorrectable coagulopathy will be excluded.
Known allergy to fluorescein or other contrast media
Patients with hemodynamic instability will be excluded
Patients with refractory hypoxemia will be excluded
Patients with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure
Patients who are unable to tolerate general anesthesia according to the anesthesiologist
Patient requires chemotherapy
Pregnant or breast feeding. Refer to section 4.5 for further detail.
Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
Pregnancy:
Women of child-bearing potential (WOCBP) who are pregnant on the day of the procedure will be excluded from the study.
Clareo Health | nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy
