Status:
RECRUITING
A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery
Lead Sponsor:
Alume Biosciences, Inc.
Conditions:
Surgery
Nerve Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery
Detailed Description
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 chara...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
October 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06662097
Start Date
October 16 2024
End Date
September 1 2025
Last Update
October 28 2024
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92037