RECRUITING

A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery

Official Title

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

Quick Facts

Study Start:2024-10-16

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06662097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Barbara Stephens

CONTACT

6145569561

barbara.stephens@alumebiosciences.com

Study Locations (Sites)

University of California San Diego

San Diego, California, 92037

United States

Collaborators and Investigators

Sponsor: Alume Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-16

Study Completion Date2025-09

Study Record Updates

Study Start Date2024-10-16

Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

Surgery
Nerve Injury
Imaging