Phase
Condition
N/ATreatment
Pure Impact
Clinical Study ID
Ages 25-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 toenrollment (i.e., oral contraceptives, contraceptive implant, barrier methods withspermicide) or abstinence.
Desire to undergo treatments on abdomen and quadriceps and/or on hamstring andglutes for strength and tone muscles.
Subject agrees to maintain their weight within 5% of total body weight and avoidsignificant dietary or exercise changes during the study.
Able and willing to comply with all visits, treatments and evaluations schedules andrequirements.
Willing to have research photos taken of treatment areas.
Able to understand and provide written Informed Consent.
Exclusion
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 asblood disorder) including but not limited to arterial circulation disorders in lowerlimbs, inflammatory disease, etc.
Active malignancy or history of malignancy in the past 5 years.
Suffering from significant concurrent illness, such as cardiac disorders, sensorydisturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinentneurological disorders, uncontrolled hypertension, or liver or kidney disease (i.e.any disease state that in the opinion of the investigator may interfere with theanesthesia, treatment, or healing process).
History of immunosuppression/immune deficiency disorders (including HIV infection orAIDS) 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 orany other metallic or electric implant anywhere in the body.
Permanent implant in the treated area such as metal plates, screws and metalpiercing, silicone implants or an injected chemical substance, unless deep enough inthe 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 drugor 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 posean 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.
Study Design
Study Description
Connect with a study center
Movassaghi Plastic Surgery & Ziba Medical Spa
Eugene, Oregon 97401
United StatesActive - Recruiting

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