Trial Outcomes & Findings for Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction (NCT NCT04012814)

Last Updated: 2024-04-23

Results Overview

Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at Week 24 using the Global Aesthetic Improvement Scale (GAIS). A score of 0 is no change, 1 - slight change, 2 - moderate change, 3 - dramatic change. An incorrect identification would result in a negative score (-1 for slight, -2 for moderate and -3 for dramatic change)

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

Week 24

Results posted on

2024-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Subject Treatment Group Treatment group received 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16. Venus Bliss: The FDA-cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, and four 1060 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.
Overall Study STARTED	39
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Subject Treatment Group Treatment group received 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16. Venus Bliss: The FDA-cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, and four 1060 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.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	1
Overall Study Adverse Event	1

Baseline Characteristics

Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subject Treatment Group n=39 Participants Treatment group received 3 diode treatments and 3 RF/PEMF treatments. Venus Bliss: The FDA-cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, and four 1060 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.
Age, Continuous	38.6 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: All subjects who had both Week 0 (baseline) and Week 24 (follow-up) photos.

Outcome measures

Outcome measures
Measure	Subject Treatment Group n=31 Participants Treatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24. Venus Bliss: The FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 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.
Change in Aesthetic Appearance From Baseline	0.97 score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Week 24

To assess subject satisfaction with treatment at the Week 24 visit using the 5-point Likert Subject Satisfaction Scale: 0 - very dissatisfied, 1 - dissatisfied, 2 - neutral, 3 - satisfied, 4 - very satisfied.

Outcome measures

Outcome measures
Measure	Subject Treatment Group n=31 Participants Treatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24. Venus Bliss: The FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 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.
Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale Satisfied (3)	11 Participants
Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale Neutral	9 Participants
Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale Dissatisfied	1 Participants
Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale Very Dissatisfied	0 Participants
Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale Very Satisfied (4)	10 Participants

SECONDARY outcome

Timeframe: Week 24

Fat thickness was measured using ultrasound at one clinical site (14 subjects in total). Change between Week 0 and Week 24 measurements is shown.

Outcome measures

Outcome measures
Measure	Subject Treatment Group n=14 Participants Treatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24. Venus Bliss: The FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 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.
Change in Fat Thickness	-6.9 percentage of baseline Standard Error 1.1

Adverse Events

Subject Treatment Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subject Treatment Group n=39 participants at risk Treatment group received up to 3 diode treatments and up to 3 RF/PEMF treatments at Week 0, 8 and 16. Venus Bliss: The FDA-cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, and four 1060 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.
Skin and subcutaneous tissue disorders Bruise	2.6% 1/39 • Number of events 1 • Up to the 24 week follow-up visit
Skin and subcutaneous tissue disorders Temporary Nodule	15.4% 6/39 • Number of events 6 • Up to the 24 week follow-up visit
Skin and subcutaneous tissue disorders Tenderness	2.6% 1/39 • Up to the 24 week follow-up visit

Additional Information

Director of Clinical Affairs

Venus Concept

Phone: 1-888-907-0115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place