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The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.
The study will evaluate the progress of up to 70 subjects after one treatment at up to 6 treatment areas on the body chosen from 2 on the neck (each treatment area approximately 1x3 cm), 2 on each underarm, 1 on each cheek, 2 on the abdomen, one on each thigh and 2 on the forehead area above the eyebrows (all approximately 6x4 cm). Subjects will be followed at 2, 5, 14, 28, 60, and 90 days after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-coring treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VENUS AIME (RoboCor) | Device | VENUS AIME is a micro-coring device of the skin that can potentially help to reduce visible skin scarring, improve skin laxity and reduce wrinkles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Cores Successfully Removed by Coring Device | Percentage of cores successfully removed by the coring device without manual removal. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Downtime, as evaluated using the Subject Questionnaire | Made of 8 questions asking if subject felt self-conscious, covered up the treatment area, avoided people, unable to perform normal activities, felt pain, discomfort or itchiness. For each, the subject may answer 1) Not at all, 2) Some of the time, or 3) Most of the time. A lower score indicates a better result. | Up to Day 90 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment pain | Subject's assessment of discomfort and pain after treatments as measured by a VAS Pain Scale on 10 cm line. 0 cm being no pain/no discomfort and 10 cm being excruciating and unbearable pain. | Day 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Gronski, PhD | Contact | 888-907-0115 | mgronski@venusconcept.com |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Gronski, PhD | Venus Concept | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berman Skin Institute | Recruiting | Los Altos | California | 94022 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D002921 | Cicatrix |
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| Le's Aesthetics | Recruiting | San Jose | California | 95112 | United States |
|
| DeNova Research | Completed | Chicago | Illinois | 60611 | United States |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |