Pure Impact to strengthen and tone the abdomen, quadriceps, hamstrings, and glutes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, non-randomized, prospective, single-center, self-controlled study that divides eligible participants into a treated group and a non-treated control group. The treated group (about 15–22 subjects) will receive six Pure Impact sessions delivered once weekly to the abdomen and quadriceps and/or the hamstrings and glutes, all completed within six weeks, with a follow-up visit about four weeks after the last treatment. The control group (about 15–22 subjects) will attend matched clinic visits without receiving the intervention. Subjects must be aged 25–60, not pregnant or lactating, agree to maintain stable weight, and allow treatment-area photos and scheduled evaluations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Movassaghi Plastic Surgery & Ziba Medical Spa
  Eugene, Oregon, United States Recruiting

Study contacts

• Study coordinator: Shlomit Mann, MSc
• Email: shlomit@sofwave.com
• Phone: 047800268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.