Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles

Launched by SOFWAVE MEDICAL LTD · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Pure Impact that aims to strengthen and tone muscles in the abdomen, thighs (quadriceps), and buttocks (glutes). The study wants to see how well this treatment works to improve muscle strength and firmness in these areas. It is an open study, meaning both the researchers and participants know what treatment is given, and participants will act as their own comparison before and after treatment.

Adults between 25 and 60 years old who want to improve muscle tone in their abdomen and legs may be eligible to join. Participants should be generally healthy, not pregnant or breastfeeding, and agree to keep their weight stable during the study. They will receive treatments on the targeted muscle areas and will need to attend all scheduled visits and evaluations, including having photos taken of the treated areas. People with certain health conditions, implants, recent surgeries, or skin problems in the treatment areas won’t qualify. If you choose to participate, you can expect a series of treatments focused on building muscle strength and tone, with careful monitoring by the study team to ensure safety and track progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects ≥ 25 years of age and ≤ 60 years of age.
• • 2. Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence.
• • 3. Desire to undergo treatments on abdomen and quadriceps and/or on hamstring and glutes for strength and tone muscles.
• • 4. Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exercise changes during the study.
• • 5. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
• • 6. Willing to have research photos taken of treatment areas.
• • 7. Able to understand and provide written Informed Consent.
• Exclusion Criteria:
• • 1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
• • 2. Medical disorder that would hinder the wound healing or immune response (such as blood disorder) including but not limited to arterial circulation disorders in lower limbs, inflammatory disease, etc.
• • 3. Active malignancy or history of malignancy in the past 5 years.
• • 4. Suffering from significant concurrent illness, such as cardiac disorders, sensory disturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinent neurological disorders, uncontrolled hypertension, or liver or kidney disease (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
• • 5. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• • 6. BMI \< 18 or \>35kg/m2
• • 7. Non-stable weight nominally ±5% in the past month.
• • 8. Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body.
• • 9. Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.
• • 10. History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) at the last 2 years.
• • 11. History of prior surgery in the treated areas at the last 2 years.
• • 12. Excessive subcutaneous fat on the treated areas.
• • 13. Abdominal or inguinal hernia
• • 14. Any active condition in the treatment area, such as open wounds, sores, psoriasis, eczema, and rash.
• • 15. Any sensitivity for hydrogel (Pure Impact electrodes pads are made of hydrogel).
• • 16. History of chronic drug or alcohol abuse.
• • 17. Muscle atrophy.
• • 18. Need for muscle rehabilitation.
• • 19. Persistent pain at the treated area.
• • 20. Inability to understand the protocol or to give informed consent.
• • 21. Unable or unwilling to comply with the study requirements and procedures.
• • 22. Currently enrolled in a clinical study of any other unapproved investigational drug or device.
• • 23. Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
• • 24. Presence of any active systemic or local infections.
• • 25. Significant scarring in the area to receive study treatment.
• • 26. Suspected or diagnosed heart problems.
• • 27. Areas of the skin that lack normal sensation.