A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery
Purpose
Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery
Conditions
- Surgery
- Nerve Injury
- Imaging
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- 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.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Defining |
A dose defining phase for each surgical setting. |
|
|
Experimental Dose Expansion |
A dose expansion phase for each surgical setting. |
|
Recruiting Locations
University of California San Diego
San Diego, California 92037
San Diego, California 92037
Contact:
Principal Investigator
Principal Investigator
More Details
- Status
- Recruiting
- Sponsor
- Alume Biosciences, Inc.
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.