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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

University of California San Diego

San Diego, California, United States, 92037

A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery | DecenTrialz