Phase
Condition
Limb Spasticity
Treatment
1064 nm diode laser
RF/PEMF
EMS
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female subjects > 18 years of age and ≤65 years of age.
Subject agrees to refrain from any new abdominal training exercises during thecourse of the study.
BMI ≤ 30 kg/m2 as determined at screening.
Subject has read and signed a written informed consent form.
Exclusion
Exclusion Criteria:
Pregnant in the last 3 months, intending to become pregnant, postpartum or nursingin the last 6 months, including presence of post-partum diastasis.
Any previous liposuction/lipo-sculpture or any type of surgical procedure in thetreatment area in the past 12 months.
History of immunosuppression/immune deficiency disorders (including AIDS and HIVinfection) or use of immunosuppressive medications last 6 months prior to and duringthe course of the study.
History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy orexcessive bleeding.
Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted),anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks oftreatment or a history of bleeding disorders.
History of skin cancer or any other cancer in the areas to be treated, includingpresence of malignant or pre-malignant pigmented lesions.
Having a permanent implant in the treatment area such as metal plates or an injectedchemical substance such as silicone or parenteral gold therapy (gold sodiumthiomalate), or drug delivery system that would prevent treatment at the treatmentsite.
Use of medications, herbs, food supplements, and vitamins known to inducephotosensitivity to light exposure at the wavelength used or history ofphotosensitivity disorder.
Suffering from significant skin conditions in the treatment area or inflammatoryskin conditions including but not limited to open lacerations, abrasions, herpessores, cold sores, active infections.
Tattoos in the treatment area
Numbness, tingling or other altered sensation in the treatment area.
Known sensitivity or allergy to isopropyl alcohol and propylene glycol, hydrogel orlatex or any substance used during treatments by the clinic (if applicable).
Unable or unwilling to comply with the study requirements.
Enrolled in a clinical study of any other investigational drug or device.
Any other condition or laboratory value that would, in the professional opinion ofthe Investigator, potentially affect the subject's response or the integrity of thedata or would pose an unacceptable risk to the subject.
Study Design
Study Description
Connect with a study center
Scripps Clinical Research - General Medicine
San Diego, California 92121
United StatesSite Not Available
Schweiger Dermatology Group
Hackensack, New Jersey 07601
United StatesSite Not Available
Tennessee Clinical Research Center
Nashville, Tennessee 37215
United StatesSite Not Available
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