Connective Tissue Defect
Conditions
Brief 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.
Interventions
DEVICEShockwave Treatment
Self-controlled, single-arm group using the Shockwave device.
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A healthy male or female 18 - 65 years of age. * 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. * Is willing to comply with all requirements of the study and sign the informed consent document.
Exclusion criteria
* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. * The subject has a pacemaker or implantable defibrillator. * The subject has a severe coagulation disorder. * The subject has open epiphyseal plates. * The subject has recently had a steroid injection. * The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study. * The subject has any condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| # of Subjects With Altered Gene Expression | 14 days post treatment | Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shockwave Device The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue.
Shockwave Treatment: Self-controlled, single-arm group using the Shockwave device. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Shockwave Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type I | 1 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type II | 2 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type III | 2 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type IV | 0 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type V | 0 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type VI | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
# of Subjects With Altered Gene Expression
Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment.
Time frame: 14 days post treatment
Population: 1 subject did not have their 14 day sample analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Shockwave Device | # of Subjects With Altered Gene Expression | 4 Participants |