A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

Launched by ALUME BIOSCIENCES, INC. · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called Bevonescein to see if it can help highlight nerves and the ureter (a tube that carries urine from the kidney to the bladder) during minimally invasive surgery. This type of surgery is typically done through small cuts in the body, and using Bevonescein may make it easier for surgeons to see important structures, potentially reducing the risk of nerve injury during the procedure.

To participate in the trial, you need to be at least 18 years old and planning to have surgery. You should also be willing to give your consent to be part of the study. However, if you have had prior surgery at the same site, have certain heart or kidney problems, or have allergies to specific medications, you may not be eligible. Participants will be monitored closely throughout the trial, and it’s important to follow all guidelines, including using effective birth control if you are sexually active. This study is currently looking for participants, so if you meet the criteria and are interested, you can ask your doctor for more information.

Gender

ALL

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.