A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlume Biosciences, Inc.
About this trial
Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Bevonescein
DrugBevonescein is a sterile solution that is intravenously administered
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Dose DefiningExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fluorescence System Survey
To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings.
Time frame
28 (+5 days)Secondary outcomes
1
To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings
The optimal dose for each of the identified surgical settings will be assessed by using three doses.
Time frame
28 (+5 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov