Studies
| Study First Submitted Date | 2019-09-12 |
| Study First Posted Date | 2019-09-16 |
| Last Update Posted Date | 2023-05-08 |
| Start Month Year | October 1, 2019 |
| Primary Completion Month Year | July 8, 2020 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-05-08 |
Detailed Descriptions
| Sequence: | 20718703 |
| Description | The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive up to 3 study treatments of the diode laser and up to 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency study treatments. Subjects will be followed at 24 weeks post diode treatments to observe their satisfaction with treatment outcomes. |
Facilities
| Sequence: | 200074861 | Sequence: | 200074862 | Sequence: | 200074863 |
| Name | Shah Aesthetic Surgery | Name | Medical Management Solutions INC | Name | SRS Dermatology |
| City | Denver | City | Foxboro | City | Woodmere |
| State | Colorado | State | Massachusetts | State | New York |
| Zip | 80206 | Zip | 02035 | Zip | 11598 |
| Country | United States | Country | United States | Country | United States |
Conditions
| Sequence: | 52162781 |
| Name | Subcutaneous Fat Disorder |
| Downcase Name | subcutaneous fat disorder |
Id Information
| Sequence: | 40152796 |
| Id Source | org_study_id |
| Id Value | BL1119 |
Countries
| Sequence: | 42562259 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55584887 |
| Group Type | Other |
| Title | Patient Treatment Group |
| Description | Up to three Diode and Radio Frequency treatments and up to three additional radio frequency treatments will be performed per patient at the discretion of the principal investigator. Diode treatments will be spaced six weeks apart while the radio frequency treatments will be spaced between 2-3 weeks apart. |
Interventions
| Sequence: | 52478027 |
| Intervention Type | Device |
| Name | Venus Bliss |
| Description | The investigational device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1064 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening. |
Design Outcomes
| Sequence: | 177350605 | Sequence: | 177350606 |
| Outcome Type | primary | Outcome Type | primary |
| Measure | Patient Overall Satisfaction | Measure | Patient Treatment Satisfaction |
| Time Frame | Week 26 | Time Frame | Week 26 |
| Description | Patients rate their satisfaction with treatment outcomes at the final follow up visit using a patient survey by answering 12 questions | Description | Patients rate their treatment satisfaction using a 5 point Likert Scale. The Likert scale ranges from 1 = very unsatisfied 2 = unsatisfied 3 = neutral 4 = satisfied 5 = very satisfied |
Browse Conditions
| Sequence: | 193456200 | Sequence: | 193456201 |
| Mesh Term | Lipid Metabolism Disorders | Mesh Term | Metabolic Diseases |
| Downcase Mesh Term | lipid metabolism disorders | Downcase Mesh Term | metabolic diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48311936 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Venus Concept |
Overall Officials
| Sequence: | 29281271 |
| Role | Study Director |
| Name | Yoni Iger |
| Affiliation | Venus Concept LTD |
Design Group Interventions
| Sequence: | 68139118 |
| Design Group Id | 55584887 |
| Intervention Id | 52478027 |
Eligibilities
| Sequence: | 30760974 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria:
Able to read, understand and voluntarily provide written informed consent. Exclusion Criteria: Pregnant, intending to become pregnant, postpartum or nursing in the last 6 months. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254304651 |
| Number Of Facilities | 3 |
| Registered In Calendar Year | 2019 |
| Actual Duration | 9 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
Designs
| Sequence: | 30507174 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
| Intervention Model Description | Single group assessed patient feedback regarding satisfaction post treatment |
Responsible Parties
| Sequence: | 28873455 |
| Responsible Party Type | Sponsor |