RecruitingPhase 2NCT06662097

A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery

Sponsor

Alume Biosciences, Inc.

Enrollment

64 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Surgery Nerve Injury Imaging

Summary

Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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.