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

Last updated: July 30, 2025
Sponsor: Sofwave Medical LTD
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Pure Impact

Clinical Study ID

NCT07094971
Sofwave27
  • Ages 25-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 toenrollment (i.e., oral contraceptives, contraceptive implant, barrier methods withspermicide) or abstinence.

  3. Desire to undergo treatments on abdomen and quadriceps and/or on hamstring andglutes for strength and tone muscles.

  4. Subject agrees to maintain their weight within 5% of total body weight and avoidsignificant dietary or exercise changes during the study.

  5. Able and willing to comply with all visits, treatments and evaluations schedules andrequirements.

  6. Willing to have research photos taken of treatment areas.

  7. Able to understand and provide written Informed Consent.

Exclusion

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 asblood disorder) including but not limited to arterial circulation disorders in lowerlimbs, 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, sensorydisturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinentneurological disorders, uncontrolled hypertension, or liver or kidney disease (i.e.any disease state that in the opinion of the investigator may interfere with theanesthesia, treatment, or healing process).

  5. History of immunosuppression/immune deficiency disorders (including HIV infection orAIDS) 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 orany other metallic or electric implant anywhere in the body.

  9. Permanent implant in the treated area such as metal plates, screws and metalpiercing, silicone implants or an injected chemical substance, unless deep enough inthe 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 drugor 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 posean 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.

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Pure Impact
Phase:
Study Start date:
July 11, 2025
Estimated Completion Date:
July 10, 2026

Study Description

Eligible subjects will be divided into two groups. The test group will include 15-22 subjects who will be treated to revive their body's functional potential, and the control group will include 15-22 subjects, who will not be treated.

The Test group will arrive to 6 Pure Impact sessions and to 4 weeks follow-up visit; while the control group will arrive to 3 visits, which are equivalent to before first treatment, last treatment (5 weeks after first visit) and 4 weeks after the second visit (equivalent to 4 weeks follow-up visit of the test group).

Subjects of the test group will receive 6 Pure Impact treatments on the abdomen and quadriceps, and/or hamstring and glutes once a week.

First treatment may be administered after the enrolment and screening at the first visit, or it may occur later following the enrolment and screening activities based on site scheduling availabilities.

Overall, all treatments are done within 6 weeks.

All subjects will return to the clinic for follow-up visit at 4±1 weeks post last treatment.

Connect with a study center

  • Movassaghi Plastic Surgery & Ziba Medical Spa

    Eugene, Oregon 97401
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.