Trials / Completed
CompletedNCT04880070
Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging
Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Cynosure, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, open label, multi-center clinical study to collect additional data and imaging for the ViaSure device.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 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the study device. Follow up visits may occur 30 and 90 days post last treatment visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Shockwave Treatment | Self-controlled, single-arm group using the Shockwave device. |
Timeline
- Start date
- 2021-03-12
- Primary completion
- 2021-05-11
- Completion
- 2021-05-11
- First posted
- 2021-05-10
- Last updated
- 2023-06-15
- Results posted
- 2023-06-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04880070. Inclusion in this directory is not an endorsement.