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Sound Wave Therapy
SoundBite Crossing System - BTK for Chronic Total Occlusion of Arteries (CaTO-PAD Trial)
N/A
Recruiting
Led By George Adams, MD
Research Sponsored by SoundBite Medical Solutions, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30 (+10/-0 days)
Awards & highlights
CaTO-PAD Trial Summary
This trial is testing a new device to see if it is safe and effective. The device is meant to be used on peripheral arteries.
Who is the study for?
This trial is for adults over 18 with Peripheral Arterial Disease, experiencing leg pain or critical limb ischemia. They must have a specific type of blockage in the leg arteries that hasn't been cleared by standard methods and are not pregnant or breastfeeding. People with severe kidney issues, life expectancy less than 30 days, or enrolled in another interfering study can't join.Check my eligibility
What is being tested?
The SoundBite Crossing System XS Peripheral is being tested to see if it's safe and works well for clearing hard-to-treat blockages in leg arteries. This study involves multiple centers where patients will openly receive this new treatment without being compared to other treatments.See study design
What are the potential side effects?
While the trial description does not specify side effects, similar procedures may cause discomfort at the insertion site, bleeding, infection risk, damage to blood vessels, or reactions related to device use.
CaTO-PAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 30 (+10/-0 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30 (+10/-0 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device Performance
Device Safety
Secondary outcome measures
Acute Lumen Gain
Antegrade Crossing
CTO Crossing Time
+5 moreCaTO-PAD Trial Design
2Treatment groups
Experimental Treatment
Group I: SoundBite Crossing System - PADExperimental Treatment1 Intervention
Use of the SoundBite Crossing System to cross calcified chronic total occlusions (above-the-knee or below-the-knee)
Group II: SoundBite Crossing System - BTKExperimental Treatment1 Intervention
Use of the SoundBite Crossing System to cross calcified chronic total occlusions (below-the-knee)
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Who is running the clinical trial?
SoundBite Medical Solutions, Inc.Lead Sponsor
4 Previous Clinical Trials
87 Total Patients Enrolled
George Adams, MDPrincipal InvestigatorUNC REX Hospital, Raleigh, NC, USA
6 Previous Clinical Trials
1,644 Total Patients Enrolled
Michael Lichtenberg, MDPrincipal InvestigatorAngiology Clinic and Vascular Centre, Arnsberg, Germany
5 Previous Clinical Trials
1,118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study and agree to participate.My kidney function is severely reduced.I am scheduled for a procedure to treat new blockages in my arteries.I have leg pain when walking or critical limb issues.I am older than 18 years.I am not pregnant or breastfeeding.I have a completely blocked artery with no blood flow except from nearby vessels.I had complications like blockage or clot after treatment on a blood vessel leading to my heart.
Research Study Groups:
This trial has the following groups:- Group 1: SoundBite Crossing System - BTK
- Group 2: SoundBite Crossing System - PAD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the sample size for this clinical trial?
"To successfully execute the trial, 110 qualified patients are needed. The sponsor of this study is SoundBite Medical Solutions, Inc., and they will be running it at UNC REX Hospital in Raleigh, North carolina as well as Palm Vascular Centers in Fort Lauderdale, Florida."
Answered by AI
Is there availability for prospective subjects to join this experiment?
"Affirmative. According to the information found on clinicaltrials.gov, this examination is still recruiting test subjects and opened its doors since October 1st 2022. Its last edition was made in September 14th of that same year and it seeks 110 individuals from 3 different medical facilities."
Answered by AI
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