RecruitingNot Applicable

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

United States44 participantsStarted 2025-07-11

Plain-language summary

Open-label, non-randomized, prospective, single-center, self-controlled clinical study.

Age range25 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects ≥ 25 years of age and ≤ 60 years of age.
✓. 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.
✓. Desire to undergo treatments on abdomen and quadriceps and/or on hamstring and glutes for strength and tone muscles.
✓. Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exercise changes during the study.
✓. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
✓. Willing to have research photos taken of treatment areas.
✓. Able to understand and provide written Informed Consent.

✕. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
✕. 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.
✕. Active malignancy or history of malignancy in the past 5 years.
✕. 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).
✕. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
✕. BMI \< 18 or \>35kg/m2
✕. Non-stable weight nominally ±5% in the past month.
✕. Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body.

Improvement rate of the muscles strength

Timeframe: 1 Month post last treatment follow up visit

NCT IDNCT07094971

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-10

Shlomit Mann, MSc

Who can participate

Age range25 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects ≥ 25 years of age and ≤ 60 years of age.
✓. 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.
✓. Desire to undergo treatments on abdomen and quadriceps and/or on hamstring and glutes for strength and tone muscles.
✓. Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exercise changes during the study.
✓. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
✓. Willing to have research photos taken of treatment areas.
✓. Able to understand and provide written Informed Consent.

✕. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
✕. 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.
✕. Active malignancy or history of malignancy in the past 5 years.
✕. 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).
✕. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
✕. BMI \< 18 or \>35kg/m2
✕. Non-stable weight nominally ±5% in the past month.
✕. Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body.