[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sofwave Medical LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100600244","pure-impact-treatment-to-strengthen-and-tone-abdomen-quadriceps-and-glutes-muscles-100600244",false,"NCT07094971","Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles","Safety and Efficacy of Pure Impact to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles","Inclusion Criteria:\n\n1. Male or female subjects ≥ 25 years of age and ≤ 60 years of age.\n2. 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.\n3. Desire to undergo treatments on abdomen and quadriceps and\u002For on hamstring and glutes for strength and tone muscles.\n4. Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exercise changes during the study.\n5. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.\n6. Willing to have research photos taken of treatment areas.\n7. Able to understand and provide written Informed Consent.\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and\u002For breast feeding.\n2. 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.\n3. Active malignancy or history of malignancy in the past 5 years.\n4. 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).\n5. History of immunosuppression\u002Fimmune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.\n6. BMI \\\u003C 18 or \\>35kg\u002Fm2\n7. Non-stable weight nominally ±5% in the past month.\n8. Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body.\n9. 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.\n10. History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) at the last 2 years.\n11. History of prior surgery in the treated areas at the last 2 years.\n12. Excessive subcutaneous fat on the treated areas.\n13. Abdominal or inguinal hernia\n14. Any active condition in the treatment area, such as open wounds, sores, psoriasis, eczema, and rash.\n15. Any sensitivity for hydrogel (Pure Impact electrodes pads are made of hydrogel).\n16. History of chronic drug or alcohol abuse.\n17. Muscle atrophy.\n18. Need for muscle rehabilitation.\n19. Persistent pain at the treated area.\n20. Inability to understand the protocol or to give informed consent.\n21. Unable or unwilling to comply with the study requirements and procedures.\n22. Currently enrolled in a clinical study of any other unapproved investigational drug or device.\n23. 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.\n24. Presence of any active systemic or local infections.\n25. Significant scarring in the area to receive study treatment.\n26. Suspected or diagnosed heart problems.\n27. Areas of the skin that lack normal sensation.",true,"ALL","25 Years","60 Years",{"count":21,"type":22},44,"ESTIMATED","INTERVENTIONAL",[25],"NA","Open-label, non-randomized, prospective, single-center, self-controlled clinical study.",[28,29],"Muscle Tone","Muscle Strength",[31,32,33,34,35,36,37,38],"Abdomen","Hamstring","Quadriceps","Glutes","skin laxity","muscle tone","muscle strength","muscle firm","RECRUITING","2025-07-30",{"date":42,"type":43},"2025-08-03","ACTUAL",{"date":45,"type":43},"2025-07-11",{"date":47,"type":22},"2026-07-10",{"name":49,"class":50},"Sofwave Medical LTD","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":16,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100541684","treatment-to-lift-facial-lax-skin-and-improve-facial-wrinkles-using-precise-and-lift-applicators-100541684","NCT06333067","Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators","Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators","Inclusion Criteria:\n\n1. Healthy female and male subjects between the ages 35-80.\n2. Non-Smoker.\n3. Fitzpatrick skin type I-VI.\n4. Desire to lift facial lax skin, neck and\u002For submental and\u002For to lift the eyebrow area and\u002For improve facial wrinkles appearance.\n5. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.\n6. Able to understand and provide written Informed Consent.\n7. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.\n8. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.\n9. Stable weight over the last 12 weeks and throughout the duration of the study.\n\nExclusion Criteria:\n\n* 1\\. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and\u002For breast feeding.\n\n  2\\. Presence of any active systemic or local infections.\n\n  3\\. Presence of active local skin disease that may alter wound healing.\n\n  4\\. Severe solar elastosis.\n\n  5\\. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.\n\n  6\\. History of chronic drug or alcohol abuse.\n\n  7\\. Excessive subcutaneous fat on the cheeks.\n\n  8\\. Significant scarring in the area to be treated.\n\n  9\\. Severe or cystic facial acne, and\u002For Accutane use during past 6 months.\n\n  10\\. Presence of a metal stent or implant in the facial area (dental implants and\u002For braces are not excluded).\n\n  11\\. Inability to understand the protocol or to provide a signed informed consent.\n\n  12\\. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 months; ablative or non-ablative resurfacing\u002Frejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.\n\n  13\\. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.\n\n  14\\. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.","35 Years","80 Years",{"count":62,"type":22},100,[25],"Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.",[66],"Lax Skin",[68,69,70,71],"neck zones.","submental","Facial","Skin laxity","2025-05-12",{"date":74,"type":43},"2025-05-13",{"date":76,"type":43},"2023-10-11",{"date":78,"type":22},"2025-11-01",{"name":49,"class":50},""]