BridgeMD
New treatment option for Peripheral Arterial Hemorrhage
Official title Onyx™ Liquid Embolic IDE Clinical Study
ClinicalTrials.gov ID: NCT06742801
What this study is testing
- What it's testing
- The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Patient is ≥ 22 years old.
- Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization...
- Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
- Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
- Target treatment area is free from prior embolization treatment.
You likely can't join if
- Pregnant or breastfeeding.
- Symptoms of active infection.
- Patient is known to be participating in the study of an investigational drug, biologic, or device.
- Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated...
- Known allergy to components of Onyx™.
- Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
See the full eligibility criteria
- Patient is ≥ 22 years old.
- Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator. In this study, peripheral vasculature is...
- Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
- Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
- Target treatment area is free from prior embolization treatment.
- Pregnant or breastfeeding.
- Symptoms of active infection.
- Patient is known to be participating in the study of an investigational drug, biologic, or device.
- Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
- Known allergy to components of Onyx™.
- Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
- More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Irvine, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- Newark, New Jersey, United States
- Albany, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Irvine, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Chicago, Illinois, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.