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Sound Wave Therapy

SoundBite Crossing System for Peripheral Arterial Disease (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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30 (+10/-0 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 (+10/-0 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device Performance
Device Safety
Secondary study objectives
Acute Lumen Gain
Antegrade Crossing
CTO Crossing Time
+4 more

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: 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)

Find a Location

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

SoundBite Crossing System-Peripheral (Sound Wave Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05551780 — N/A
Chronic Total Occlusion of Arteries Research Study Groups: SoundBite Crossing System - BTK, SoundBite Crossing System - PAD
Chronic Total Occlusion of Arteries Clinical Trial 2023: SoundBite Crossing System-Peripheral Highlights & Side Effects. Trial Name: NCT05551780 — N/A
SoundBite Crossing System-Peripheral (Sound Wave Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551780 — N/A
~46 spots leftby Dec 2025
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