Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alume Biosciences, Inc.
This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Must be a minimum of 18 years of age
Study participant is planning to proceed with surgery
Willing to provide informed consent
Sexually active patients must be willing to use an acceptable form of contraceptive while participating and 30 days after.
Females of childbearing potential must have a negative pregnancy test at screening and during the study.
You may not be if
Patient has had prior surgery at the intended surgical site.
Patient has abnormal cardiac rhythm not controlled by medication.
Patient has moderate to severe renal impairment.
Patient has a history of fluorescein allergy.
Patient has a history of drug-related anaphylactic.
Presence of a concurrent disease or condition that may interfere with study participation.
Presence or history of any condition that, in the view of the investigator, places the patient at high risk of treatment compliance.
Use of any Investigational Product or investigational medial device within 30 days prior to screening.
