Recruiting

Observational Study

Sponsor:

Sofwave Medical LTD

Code:

NCT07094971

Conditions

Muscle Tone

Muscle Strength

Eligibility Criteria

Sex: All

Age: 25 - 60

Healthy Volunteers: Accepted

Interventions

Pure Impact

Study Details

Brief summary:

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

Conditions

Muscle Tone

Muscle Strength

Study ID

NCT07094971

Start date

Jul 11, 2025

Status verified date

Jul, 2025

Completion date

Jul 10, 2026

Anticipated

Primary completion date

Jul 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Muscle strength

Pure Impact is an EMS module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.

no intervention: Control

Control group will be followed but will not be treated.

Interventions

Pure Impact

Pure Impact is an EMS module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.

Primary outcome measure

  • Improvement rate of the muscles strength [ Time Frame: 1 Month post last treatment follow up visit ]

Central Contacts and Locations

Central contacts

Locations

Movassaghi Plastic Surgery & Ziba Medical Spa

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Principal Investigator:

Kiya Movassaghi, MD

More Information

Sponsor

Sofwave Medical LTD

Last update posted

Aug 3, 2025

Last verified

Jul, 2025

Keywords

  • Abdomen
  • Hamstring
  • Quadriceps
  • Glutes
  • skin laxity
  • muscle tone
  • muscle strength
  • muscle firm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sofwave Medical LTD on 2025-08-03.