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Procedure
Bevonescein for Surgery
San Diego, CA
Phase 2
Recruiting
Research Sponsored by Alume Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study participant is planning to proceed with surgery
Must be a minimum of 18 years of age
Must not have
Patient has had prior surgery at the intended surgical site
Patient has abnormal cardiac rhythm not controlled by medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 (+5 days)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if Bevonescein can help highlight nerves and the ureter in patients having minimally invasive surgery.
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Who is the study for?
This trial is for patients who are about to have minimally invasive surgery in the abdominopelvic area. The study aims to include those who could benefit from better visualization of nerves and ureters during their procedure.Check my eligibility
What is being tested?
The trial is testing Bevonescein, a substance used during surgery to make nerves and the ureter more visible. This may help surgeons avoid damaging these structures while operating.See study design
What are the potential side effects?
Since specific side effects of Bevonescein aren't provided, they might range from allergic reactions at the site of injection to potential changes in vision if it's similar to other diagnostic imaging agents.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am planning to have surgery.
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I am at least 18 years old.
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I am not pregnant and will take tests to confirm this during the study.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery before at the same spot where another surgery is planned.
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My heart rhythm is irregular and not controlled by medication.
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My kidneys do not work well.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 (+5 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 (+5 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fluorescence System Survey
Secondary study objectives
To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
A dose expansion phase for each surgical setting.
Group II: Dose DefiningExperimental Treatment1 Intervention
A dose defining phase for each surgical setting.
Find a Location
Closest Location:University of California San Diego· San Diego, CA· 1955 miles
Who is running the clinical trial?
Alume Biosciences, Inc.Lead Sponsor
3 Previous Clinical Trials
321 Total Patients Enrolled
2 Trials studying Surgery
241 Patients Enrolled for Surgery