Actively Recruiting
Pure Impact Treatment 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
CONDITIONS
Official 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 25 to 60 years of age
- Not pregnant or lactating and must be post-menopausal, surgically sterilized, or using medically acceptable birth control for at least 3 months prior
- Desire to receive treatment on abdomen and quadriceps and/or hamstring and glutes for muscle strength and tone
- Agree to maintain weight within 5% of total body weight and avoid major dietary or exercise changes during the study
- Able and willing to attend all visits, treatments, and evaluations as scheduled
- Willing to have research photos taken of treatment areas
- Able to understand and provide written informed consent
You will not qualify if you...
- Pregnant, planning pregnancy, given birth less than 3 months ago, or breastfeeding
- Medical disorders affecting wound healing or immune response, including arterial circulation disorders and inflammatory diseases
- Active cancer or history of cancer in the past 5 years
- Significant illnesses such as cardiac disorders, sensory disturbances, diabetes, epilepsy, lupus, porphyria, neurological disorders, uncontrolled hypertension, liver or kidney disease
- History of immunosuppression or immune deficiency, including HIV/AIDS, or use of immunosuppressive medications
- Body mass index less than 18 or greater than 35 kg/m2
- Unstable weight (more than ±5%) in the past month
- Presence of active implanted devices like pacemakers or defibrillators
- Permanent implants in treated areas including metal plates, screws, piercings, silicone implants, or injected substances unless deeply placed
- Fat reduction procedures or surgery in treated areas within the last 2 years
- Excessive subcutaneous fat or hernia in treated areas
- Active skin conditions or wounds in the treatment areas
- Sensitivity to hydrogel used in electrode pads
- History of chronic drug or alcohol abuse
- Muscle atrophy or need for muscle rehabilitation
- Persistent pain in treated areas
- Inability to understand protocol or provide informed consent
- Unwillingness or inability to comply with study procedures
- Participation in other investigational drug or device studies
- Any condition that may affect study response, data integrity, or participant safety as judged by the investigator
- Active systemic or local infections
- Significant scarring in treatment areas
- Suspected or diagnosed heart problems
- Areas of skin lacking normal sensation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
R
Ruthie Amir, MD
CONTACT
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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