Using Bevonescein to Improve Nerve and Ureter Visibility During Surgery
Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery
This study is testing if a new dye called Bevonescein can help surgeons see nerves and ureters better during minimally invasive surgeries to improve patient outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alume Biosciences, Inc. Industry-sponsored |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06662097 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of Bevonescein, administered intravenously, in patients undergoing minimally invasive surgery. The focus is on determining the appropriate dose of Bevonescein needed to produce a fluorescence signal that highlights nerves and ureters, aiding in surgical imaging. The study also aims to characterize the pharmacokinetics of Bevonescein in this patient population. By enhancing visibility of critical structures during surgery, the study seeks to improve surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for minimally invasive surgery and can provide informed consent.
Not a fit: Patients with prior surgery at the intended surgical site or those with severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective surgical procedures by improving the visualization of nerves and ureters.
How similar studies have performed: While the use of fluorescence imaging in surgery is gaining traction, this specific application of Bevonescein is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California
- University of California San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Barbara Stephens
- Email: barbara.stephens@alumebiosciences.com
- Phone: 6145569561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.