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Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406935
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.

Brief Summary:
Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group

Condition or disease Intervention/treatment Phase
Circumferential Reduction Device: treatment with the study device (NuEra) Not Applicable

Detailed Description:
The study design to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group. each group has a different radio-frequency. The study hypothesis is that NuEra Tight is safe and will cause a reduction in abdominal circumferential after treatment and at 12 week post last treatment within each treatment group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Multi-arm, prospective, multi-center, baseline-controlled study, designed to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction of the abdomen area at three different frequencies.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Active Comparator: 475 KHz
NuEra device treatment using 475 KHz
Device: treatment with the study device (NuEra)

Multi-arm, prospective, multi-center, baseline-controlled study:

Arm 1: NuEra treatment using 475 KHz Arm 2: NuEra treatment using 1 MHz Arm 3: NuEra treatment using 2 MHz


Active Comparator: 1 MHz
Arm 2: NuEra device treatment using 1 MHz
Device: treatment with the study device (NuEra)

Multi-arm, prospective, multi-center, baseline-controlled study:

Arm 1: NuEra treatment using 475 KHz Arm 2: NuEra treatment using 1 MHz Arm 3: NuEra treatment using 2 MHz


Active Comparator: 2 MHz
NuEra device treatment using 2 MHz
Device: treatment with the study device (NuEra)

Multi-arm, prospective, multi-center, baseline-controlled study:

Arm 1: NuEra treatment using 475 KHz Arm 2: NuEra treatment using 1 MHz Arm 3: NuEra treatment using 2 MHz





Primary Outcome Measures :
  1. Reduction in abdominal circumference [ Time Frame: one month ]
    Change in abdominal circumference in cm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Male or Female, 18 to 65 years of age 2. Has visible fat bulges on the abdomen 3. Has a Body Mass Index (BMI) ≤ 30 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.

    5. Subject must agree to not undergo any other procedure(s) in the abdominal region during the study period.

    6. Subject who is willing to refrain from a change in diet/ exercise/medication regimen for the entire course of the study and to maintain his/her weight during the study within 5% of baseline weight measurement.

    7. Subject must agree to adhere to the follow-up schedule and study instructions.

    8. Subject must be able to read, understand and sign the Informed Consent Form. 9. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.

    10. If the subject is a female and not pregnant or lactating, she must be either post-menopausal, surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrolment (i.e oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence) and during the entire course of the study, and no plans to become pregnant.

Exclusion Criteria:

  1. Subject had any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolipolysis or light-based treatments.
  2. Subject had any prior invasive cosmetic surgery to the target area, such as liposuction
  3. Subject has scar tissue in and around the treatment area (i.e. cesarean-section or traumatic injury scar)
  4. Subject has tattoo(s) that extend over a substantial portion of the treatment area
  5. Subject is currently taking medications or supplements for weight-loss or metabolism support/enhancement or has a history of taking such medications or supplements within 3 months.
  6. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
  7. Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
  8. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
  9. History of any disease or condition that could impair wound healing.
  10. Infection, dermatitis, rash or other skin abnormality in the target area.
  11. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing
  12. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, and abdominal aortic aneurysm
  13. Significant concurrent illness, such as diabetes mellitus, hyperlipidemia, liver disease, HIV positive, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
  14. History of skin disease in the treatment area or known epidermal or dermal disorders (particularly if involving collagen or microvascularity)
  15. Severe skin laxity in the treatment area
  16. Extensive collection of visceral adipose tissue or abdominal wall diastasis or hernia on physical examination
  17. Obesity ≥30 BMI
  18. Diagnosed or documented immune system disorders.
  19. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
  20. Participation in a clinical trial of another device or drug within 6 months of study participation, or during the study period.
  21. Pregnant or currently breastfeeding.
  22. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
  23. Known allergy to general and/or topical anesthetic

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406935


Contacts
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Contact: Gally Glass +9723896645 gally.glass@lumenis.com
Contact: Alina Timmerman +972542080570 Alina.Timmerman@lumenis.com

Locations
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United States, Massachusetts
Skincare Physicians Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Kathleen Petrell    617-848-1638      
United States, New York
Dermatology and Laser Surgery Center of New York Recruiting
New York, New York, United States, 10028
Contact: Micayla Andersen    212-570-2067    mandersen@nyderm.org   
Contact: Eliana Schmidt    212-570-2067    efernandez@nyderm.org   
Sponsors and Collaborators
Lumenis Ltd.
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Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT04406935    
Other Study ID Numbers: NuEra Tight-19-01
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No