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Recruiting NCT06662097

A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

Phase II Interventional Surgery Nerve Injury Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bevonescein.
Who it may be relevant to
Registry conditions: Surgery, Nerve Injury, Imaging. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery

Overview

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.

Interventions

  • Drug Bevonescein
    Bevonescein is a sterile solution that is intravenously administered

Primary outcome measures

  • Fluorescence System Survey [Time frame: 28 (+5 days)]
Secondary outcome measures (1)
  • To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings [Time frame: 28 (+5 days)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of California San Diego — San Diego

Identifiers

NCT: NCT06662097 · ALM-488-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗