NCT06662097

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Alume Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.

Conditions

• Surgery
• Nerve Injury
• Imaging

Interventions

Type	Name	Description
DRUG	Bevonescein	Bevonescein is a sterile solution that is intravenously administered

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2024-10-28
• Last updated: 2024-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study