NL-OMON51182撤回不适用
Multi Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area (NuCOOL) - MED-MA-PLS-0647
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Participant must be in good health as determined by medical history,
- •physical examination, vital signs, and investigator*s judgment, including no
- •known active pandemic infection.
- •2. Participant (healthy volunteers) has read and signed the study written ICF.
- •3. Male or female participant 22 to 65 years of age inclusive at screening.
- •4. Participant has clearly visible and palpable fat in the abdomen and flanks,
- •and participant may also be assessed for visible and palpable fat in one or
- •more of the following body areas: left and right lower aspects of the upper
- •arms, left and right inner thigh, left and right outer thigh, or submental
- •area, which in the investigator*s opinion is appropriate for and may benefit
- •from treatment.
- •5. Participant agrees to receive treatment of the abdomen and flanks
- •(collectively, the midsection) and has option to receive treatment to at least
- •1 additional body area listed in criterion 4.
- •6. Participant has not had weight change fluctuations exceeding 5% of body
- •weight in the preceding month.
- •7. Participant has a BMI of * 18.5 and < 30. BMI is defined as weight in
- •kilograms divided by height in meters squared (kg/m2).
- •8. Participant agrees to maintain weight (ie, within 5% of body weight) by not
- •making any changes in diet or exercise routine during the course of the study.
- •9. Participant agrees to have photographs taken of the treatment area(s) during
- •the scheduled time periods
排除标准
- •1. Participant has a history of an invasive fat reduction procedure (eg,
- •liposuction, surgery, lipolytic agents, etc) within or adjacent to the area
- •being considered for treatment.
- •2. Participant has implants (eg, breast implants) in or immediately adjacent to
- •the area of intended treatment.
- •3. Participant has a history of prior surgery or scar tissue related to the
- •area being considered for treatment.
- •4. Participant has a known history of cryoglobulinemia, cold urticaria, cold
- •agglutinin disease, or paroxysmal cold hemoglobinuria.
- •5. Participant has a known sensitivity to cold or has any condition with a
- •known response to cold exposure that limits blood flow to the skin, such as
- •cold urticaria, Raynaud*s disease, or chilblains (pernio).
- •6. Participant with a clinically significant bleeding disorder, or concomitant
- •use of blood thinners, or is taking any medication that, in the investigator*s
- •opinion, may significantly increase the participant*s risk of bruising or
- •bleeding. Participant on low dose aspirin for medical condition is excluded if
- •the medical history suggests significant risk of bruising or bleeding per
- •investigator*s clinical judgement.
- •7. Participant has a history of carpal tunnel syndrome, compartment syndrome,
- •or deep vein thrombosis in the upper or lower extremities (only applicable for
- •participants receiving treatment to the upper arms or thighs).
- •8. Participant is currently taking or has taken diet pills or weight control
- •supplements within the past 6 months.
- •9. Participant has any skin conditions, such as moderate to excessive skin
- •laxity, open wound, or scars, and active infection, eczema, dermatitis or
- •rashes in the location of the treatment sites that may interfere with the
- •treatment or evaluation (stretch marks are not an exclusion).
- •10. Participant has an active implanted device such as a pacemaker,
- •defibrillator, drug delivery system, or any other metal-containing implant,
- •within or adjacent to the area being considered for treatment.
- •11. Participant (WOCBP) is pregnant or intending to become pregnant in the next
- •3 to 6 months and does not agree to use reliable contraception during the study.
- •12. Participant is lactating or has been lactating in the past 6 months.
- •13. Participant is unable or unwilling to comply with the study requirements.
- •14. Participant is currently enrolled in a clinical study of any unapproved
- •investigational device, investigational product, or any other type of medical
- •research judged not to be scientifically or medically compatible with this
- •15. Participant has any other condition or laboratory value that would, in the
- •professional opinion of the investigator, potentially affect the participant*s
- •response or the integrity of the data or would pose an unacceptable risk to the
- •participant.
- •16. Participant has had a non-invasive fat reduction and/or body contouring
- •procedure in the area(s) of intended treatment within the past 12 months.
- •17. Participant needs to administer, or has a known history of subcutaneous
- •injections, into the area(s) of intended treatment (eg, cortisone, heparin,
- •insulin) within the past 6 months.
- •18. Participant with known sensitivity or allergy to fructose, glycerin,
- •isopropyl alcohol, or propylene glycol.
- •19. Participant has impaired peripheral circulation in the area to be treat
研究者
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