Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
Sofwave Medical LTD · NCT07094971
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 25–60 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 44
- US sites recruiting
- 1
- Study start
- July 11, 2025
- Record last updated
- August 3, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
Being studied: Pure Impact
Conditions: Muscle Tone; Muscle Strength
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) at the last 2 years.
- History of prior surgery in the treated areas at the last 2 years.
- Excessive subcutaneous fat on the treated areas.
- Abdominal or inguinal hernia
- Any active condition in the treatment area, such as open wounds, sores, psoriasis, eczema, and rash.
- Any sensitivity for hydrogel (Pure Impact electrodes pads are made of hydrogel).
- History of chronic drug or alcohol abuse.
- Muscle atrophy.
- Need for muscle rehabilitation.
- Persistent pain at the treated area.
- Inability to understand the protocol or to give informed consent.
- Unable or unwilling to comply with the study requirements and procedures.
- Currently enrolled in a clinical study of any other unapproved investigational drug or device.
- 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.
- Presence of any active systemic or local infections.
- Significant scarring in the area to receive study treatment.
- Suspected or diagnosed heart problems.
- Areas of the skin that lack normal sensation.
Recruiting US locations
Movassaghi Plastic Surgery & Ziba Medical Spa
Eugene, OR 97401
Site contact: janna Check · 541-686-8700 · janna@drmovassaghi.com
Study contacts (from the official record)
- Shlomit Mann, MSc · 047800268 · shlomit@sofwave.com
- Ruthie Amir, MD · 043003164 · ruthie@sofwave.com
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