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Study of Bevonescein for Nerve and Ureter Imaging During Surgery

This study is testing a solution called Bevonescein, given through an IV (into your vein), during abdominopelvic surgery. The goal is to see if Bevonescein can help highlight nerves and the ureter (the tube that carries urine from your kidney to your bladder) during minimally invasive surgery. Researchers want to understand how safe and effective Bevonescein is, how your body processes it, and what dose is best for imaging. You might be able to join if you are at least 18 years old, planning to have surgery, and willing to use birth control if you are sexually active. The main way they will measure success is by using a special fluorescence system to survey the results about 28 days after your surgery. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 64 participants. It is a feasibility study, meaning it's an early look at how well Bevonescein works.
What's involved
You would receive Bevonescein as an IV infusion during your minimally invasive surgery. You will also have a survey about 28 days after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 28 days after treatment for the primary endpoint.

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NCT06662097

A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

Recruiting
PHASE2Ages 18+InterventionalPrevention
Alume Biosciences, Inc.
~64 participants
Updated 2024-10-28 on ClinicalTrials.gov
What's tested:Bevonescein

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fluorescence System Survey
Measured over 28 (+5 days)

Conditions

Surgery
Nerve Injury
Imaging

Explore related trials

Nerve Damage

Where it's being run

1 sites across 1 states
California1

Who to contact

Barbara Stephens
[email protected]
6145569561
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Fluorescence System Survey28 (+5 days)

    To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings.