NCT07094971 Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
| NCT ID | NCT07094971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sofwave Medical LTD |
| Condition | Muscle Tone |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2026-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2025-07-11 with a primary completion date of 2026-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
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.
Contact & Investigator
Ahlam Safadi, BSC
STUDY DIRECTOR
Sofwave Medical LTD
Frequently Asked Questions
Who can join the NCT07094971 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 60 Years, studying Muscle Tone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07094971 currently recruiting?
Yes, NCT07094971 is actively recruiting participants. Contact the research team at shlomit@sofwave.com for enrollment information.
Where is the NCT07094971 trial being conducted?
This trial is being conducted at Eugene, United States.
Who is sponsoring the NCT07094971 clinical trial?
NCT07094971 is sponsored by Sofwave Medical LTD. The principal investigator is Ahlam Safadi, BSC at Sofwave Medical LTD. The trial plans to enroll 44 participants.