Shockwave Treatment for Connective Tissue Disorder

Overseen By Jamie Trimper

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cynosure, Inc.

Disqualifiers: Pregnancy, Pacemaker, Coagulation disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the ViaSure device by collecting data and images to assess its effectiveness in treating connective tissues with shock wave therapy. The device will be applied to various body areas to evaluate its effectiveness and safety. Ideal candidates are healthy individuals willing to undergo this treatment and agree to avoid other procedures on the same areas during the study. As an unphased trial, participants contribute to innovative research and may benefit from cutting-edge treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the ViaSure device is safe for treating connective tissue?

Research has shown that the ViaSure device, which uses shockwave therapy, has been tested for safety in treating conditions like erectile dysfunction (ED). These studies have found it to be generally well-tolerated. ViaSure’s SoftWave™ Technology is recognized as a safe and effective method for improving blood flow issues, such as those seen in ED.

ViaSure's shockwave therapy offers a promising alternative to traditional treatments, with reports suggesting it is safer while maintaining effectiveness. However, similar shockwave treatments carry a higher risk of tissue problems, like tearing or puncturing, especially in areas with significant calcium build-up.

Overall, while the ViaSure device has been successfully used in areas like ED treatment, potential participants should consult their healthcare provider to fully understand the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ViaSure device is unique because it uses shockwave therapy to treat connective tissue across multiple areas of the body. Unlike traditional treatments that often focus on medication or invasive procedures, this device leverages sound waves to stimulate tissue repair and regeneration. Researchers are excited about its potential to offer a non-invasive alternative that could lead to faster recovery times and fewer side effects compared to standard options.

What evidence suggests that the ViaSure device is effective for treating connective tissue?

Research has shown that the ViaSure device, used in this trial, employs shock wave therapy, which effectively treats certain conditions. For example, studies on similar treatments have found that more than half of the patients experienced improvement in conditions like erectile dysfunction by increasing blood flow. One study reported positive results lasting about 8 weeks, helping patients achieve better erections. Clear evidence supports the effectiveness of this therapy for erectile dysfunction, suggesting it might also benefit other connective tissue issues treated by the ViaSure device. ^{5 6 7 8 9}

Who Is on the Research Team?

Jennifer Civiok

Principal Investigator

Cynosure, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing to undergo treatments with the SoftWave device.

Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.

Understands and accepts the obligation and is logistically able to be present for all visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive up to 5 treatments with the ViaSure device

Varies

Up to 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ViaSure device

How Is the Trial Designed?

Group I: Shockwave Device Experimental Treatment 1 Intervention

The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue.

Who Is Running the Clinical Trial?

Cynosure, Inc.

Lead Sponsor

Trials

52

Recruited

1,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04880070

Post-Market Clinical Follow Up Study to Collect Additional ... The intended use of the ViaSure device used in this study is to assess the usability and tissue response to shock wave treatment. Detailed Description. Up to 50 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10890328/

Effectiveness of Low-Intensity Extracorporeal Shock Wave ... The results showed that, at 6 months of treatment with active pelvic floor work and biofeedback, more than half of the patients in the study improved. In the ...

3. excellencemen.ca excellencemen.ca/blog/shock-wave-therapy-for-ed/

What is Shock Wave Therapy for ED? Exploring the Latest ... Positive outcome endured for approximately 8 weeks resulting in improved penile flow so better erections could occur during sexual intercourse ...

4. medrxiv.org medrxiv.org/content/10.1101/2024.12.10.24318762v1.full-text

Extracorporeal shock wave therapy for erectile dysfunction There is clear evidence that ESWT for ED is effective and can therefore be a valuable treatment modality in the management of ED.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07204210

Study Details | NCT07204210 | Comparison of Treatment ... The present study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT), a frequently used treatment for patients with ...

6. shockwavemedical.com shockwavemedical.com/isi/

Important Safety Information The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7658170/

Retrospective comparison of focused shockwave therapy ... Low-intensity shockwave therapy (SWT) is an emerging treatment for erectile dysfunction (ED). Devices used for SWT include focused shockwave therapy (fSWT) ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03067987

Safety and Efficacy of Low Intensity Shockwave for the ... Linear Shockwaves (LISW), as a treatment for erectile dysfunction has been in evaluation in contemporary medicine, It has been in use for the last three years.

9. precisionclinictoronto.ca precisionclinictoronto.ca/treatments/viasure-shockwave-therapy/

VIASURE™ Shockwave Therapy Treatments for ED ViaSure's SoftWave™ Technology provides a safe and effective procedure to improve vascular related erectile function, restoring spontaneity in patients lives ...