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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment 1 and 3; day 0 and day 28 (arm a and b). treatment 1 and 5; day 0 and day 28 (arm c). follow-up 1: 84 days (arm a & b); 63 days (arm c). follow-up 2: 140 days (arms a & b); 119 days (arm c)
Awards & highlights
Study Summary
This trial is testing whether electrical muscle stimulation, a diode laser, pulsed electromagnetic field, or vacuum assisted radio frequency can help with fat reduction, body contouring, and aesthetic improvement.
Who is the study for?
This trial is for men and women aged 18-65 with a BMI of ≤30 kg/m2 who are not currently changing their abdominal exercise routine. Participants must consent to the study's terms and cannot have had recent surgery or skin conditions in the treatment area, be pregnant or nursing, have immune deficiencies, bleeding disorders, certain chronic diseases, tattoos in the treatment area, or be on drugs that affect bleeding or cause light sensitivity.Check my eligibility
What is being tested?
The study tests electrical muscle stimulation (EMS), a 1064 nm diode laser, pulsed electromagnetic field (PEMF), and radio frequency (RF) treatments using Venus Bliss Max for non-invasive body contouring and fat reduction. It's a multi-center trial where participants are randomly assigned to one of three groups without knowing which group they're in.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, redness or swelling, bruising from RF/PEMF application; however specific side effects will depend on individual reactions to EMS and laser treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment 1 and 3; day 0 and day 28 (arm a and b). treatment 1 and 5; day 0 and day 28 (arm c). follow-up 1: 84 days (arm a & b); 63 days (arm c). follow-up 2: 140 days (arms a & b); 119 days (arm c)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment 1 and 3; day 0 and day 28 (arm a and b). treatment 1 and 5; day 0 and day 28 (arm c). follow-up 1: 84 days (arm a & b); 63 days (arm c). follow-up 2: 140 days (arms a & b); 119 days (arm c)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blinded, independent photo review comparing the pre-treatment and post-treatment photographs.
Secondary outcome measures
Blinded Investigator review comparing the pre-treatment photographs and post-treatment Follow-up live assessment.
Change in Anthropometric measurements: Abdominal Circumference
Change in Anthropometric measurements: Abdominal Skinfold Thickness
+2 moreOther outcome measures
Change in Abdominal Magnetic Resonance Imaging (MRI) (optional)
Change in Abdominal Ultrasound images (optional)
Trial Design
3Treatment groups
Active Control
Group I: Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF)Active Control3 Interventions
Arm A: Three (3) diode laser treatments treatments at days 0, 28 and 56 (±2 days). Subjects will also receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days).
Group II: Arm B: EMS/RF Arm (EMS + RF/PEMF)Active Control2 Interventions
Arm B: Subjects will receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days).
Group III: Arm C: EMS Arm (EMS only)Active Control1 Intervention
Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days).
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Who is running the clinical trial?
Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,306 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You promise not to do any new exercises that focus on your abdomen during the study.Your body mass index (BMI) is less than or equal to 30, which will be checked before the study starts.You have read and signed a paper that explains the study and your involvement in it.You have significant skin problems in the area where the treatment would be given, like open wounds, sores, or infections.You are between 18 and 65 years old.You are between 18 and 65 years old.You had liposuction or other surgery in the treatment area within the last year.You have a history of immune system problems or have taken medications that weaken your immune system in the past 6 months.You have a history of high cholesterol, diabetes, hepatitis, blood clotting problems, or excessive bleeding.You have taken certain blood-thinning or anti-inflammatory medicines within the last 2 weeks, or have a history of bleeding disorders.You have had skin cancer or any other cancer in the areas that will be treated, including any suspicious moles or spots.You have a permanent implant or injected substance in the area where the treatment will be given.You take medications or use products that make your skin sensitive to light, or you have a history of being sensitive to light.You have tattoos in the area where the treatment will be given.You have numbness, tingling, or unusual feeling in the area where the treatment is given.You are allergic to isopropyl alcohol, propylene glycol, hydrogel, latex, or any other substances used during treatments at the clinic.Your body mass index (BMI) is less than or equal to 30.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF)
- Group 2: Arm B: EMS/RF Arm (EMS + RF/PEMF)
- Group 3: Arm C: EMS Arm (EMS only)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Tennessee Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
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