Actively Recruiting
Safety and Efficacy of Pure Impact to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
Led by Sofwave Medical LTD · Updated on 2025-08-03
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of Pure Impact, an electrical muscle stimulation device, to strengthen and tone muscles of the abdomen, quadriceps, hamstrings, and glutes. The study is an open-label, non-randomized, prospective clinical trial involving adults aged 25 to 60 years, including healthy volunteers who wish to improve muscle tone and strength. Participants will be divided into two groups: a test group receiving six weekly Pure Impact treatments over about six weeks, and a control group that will not receive treatment but will attend scheduled visits for comparison purposes. The Pure Impact device delivers electrical impulses via electrodes placed on the skin near muscles to stimulate them. Both groups will have follow-up visits four weeks after the last treatment or equivalent timing. During the study, participants will undergo assessments of muscle strength before, during, and after the treatment period. Research photos of treatment areas will be taken, and weight and lifestyle habits will be monitored to ensure consistency. The primary outcome measured is the improvement rate of muscle strength one month after the final treatment. The total participation duration includes treatment and follow-up visits over approximately 10 weeks.
CONDITIONS
Brief Title
Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 25 to 60 years
- Not pregnant or lactating and must be post-menopausal, surgically sterilized, or using acceptable birth control for at least 3 months before enrollment
- Desire to undergo treatments on abdomen and quadriceps and/or hamstring and glutes to strengthen and tone muscles
- Agree to maintain body weight within 5% and avoid major diet or exercise changes during the study
- Able and willing to attend all visits, treatments, and evaluations
- Willing to have research photos taken of the treatment areas
- Able to understand and provide written informed consent
You will not qualify if you...
- Pregnant, planning to become pregnant, given birth less than 3 months ago, or breastfeeding
- Medical conditions that impair wound healing or immune response, including blood disorders and arterial circulation issues
- Active cancer or history of cancer in the past 5 years
- Significant illnesses such as cardiac disorders, sensory disturbances, diabetes, epilepsy, lupus, neurological disorders, uncontrolled hypertension, or liver/kidney disease
- History of immune deficiency or current use of immunosuppressive medications
- Body mass index less than 18 or greater than 35 kg/m2
- Unstable weight beyond ±5% in the past month
- Active implanted devices like pacemakers or metal implants in treatment areas
- Recent fat reduction procedures or surgeries in treated areas within 2 years
- Excessive subcutaneous fat or hernia in the treatment area
- Active skin conditions, sensitivity to hydrogel, chronic drug or alcohol abuse, muscle atrophy, or need for muscle rehabilitation
- Persistent pain in treated areas or inability to consent or comply with study procedures
- Enrollment in other investigational studies
- Any other condition that might affect response or safety as judged by the investigator
- Presence of active infections, significant scarring, suspected heart problems, or areas with loss of normal sensation in treatment regions
- Permanent implants in treated areas such as metal plates, screws, or silicone implants unless deep beneath the bone surface
- Skin conditions like open wounds, sores, psoriasis, eczema, or rash in treatment areas
- Sensitivity to hydrogel electrode pads used in treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants in the test group receive 6 Pure Impact sessions to strengthen and tone abdomen, quadriceps, hamstrings, and glutes muscles. The control group does not receive treatment but attends visits for observation.
6 weekly visits for the test group; 3 visits for the control group
Duration - 4 weeks ± 1 week
Participants return for a follow-up visit to assess muscle strength improvement approximately 4 weeks after their last treatment or equivalent timing for the control group.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Movassaghi Plastic Surgery & Ziba Medical Spa
Eugene, Oregon, United States, 97401
Actively Recruiting
Research Team
S
Shlomit Mann, MSc
R
Ruthie Amir, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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