Imaging, Nerve Injury, Surgery
Conditions
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 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
DRUGBevonescein
Bevonescein is a sterile solution that is intravenously administered
Sponsors
Alume Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study will begin with a dose-defining stage in each surgical setting. Once dose defining is complete, the study will proceed to a dose expansion phase for each surgical setting.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescence System Survey | 28 (+5 days) | To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings | 28 (+5 days) | The optimal dose for each of the identified surgical settings will be assessed by using three doses. |
Countries
United States
Contacts
Primary ContactBarbara Stephens
Outcome results
None listed