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

Safety and Efficacy of Pure Impact to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles

This test tries six weekly Pure Impact sessions to see if they can strengthen and tone the abdomen, quadriceps, hamstrings, and glutes in adults aged 25–60.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 25 Years to 60 Years
• Sex: All
• Sponsor: Sofwave Medical LTD (Industry-sponsored)
• Locations: 1 site (Eugene, Oregon)
• Trial ID: NCT07094971 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 25–60 who want non-surgical strengthening/tone of the abdomen, quadriceps, hamstrings, or glutes, are not pregnant or breastfeeding, can keep weight stable, and can attend weekly clinic visits are ideal candidates.

Not a fit: People who are pregnant, breastfeeding, recently gave birth (under 3 months), plan significant weight or exercise changes, or have medical issues that exclude them from participation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the procedure could offer a non-surgical option to improve muscle strength and tone and may reduce mild skin laxity in treated areas.

How similar studies have performed: Other focused muscle-stimulation devices (for example HIFEM-type devices) have shown improvements in muscle tone and strength in prior studies, but Pure Impact itself has limited published clinical data.

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.

Where this trial is running

Eugene, Oregon

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

Study contacts

• Study coordinator: Shlomit Mann, MSc

Conditions Muscle Tone; Muscle Strength; Abdomen; Hamstring; Quadriceps; Glutes; skin laxity; muscle tone