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

NCT04406935 | Completed

• 1 other identifier: NuEra Tight-19-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Conditions

Circumferential Reduction

Outcome Measures

Primary Outcomes (1)

• Reduction in abdominal circumference

  Change in abdominal circumference in cm

  one month

Study Arms (3)

475 KHz

ACTIVE COMPARATOR

NuEra device treatment using 475 KHz

Device: treatment with the study device (NuEra)

1 MHz

ACTIVE COMPARATOR

Arm 2: NuEra device treatment using 1 MHz

Device: treatment with the study device (NuEra)

2 MHz

ACTIVE COMPARATOR

NuEra device treatment using 2 MHz

Device: treatment with the study device (NuEra)

Interventions

treatment with the study device (NuEra) DEVICE

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

1 MHz; 2 MHz; 475 KHz

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Subject must agree to not undergo any other procedure(s) in the abdominal region during the study period.
• \. 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.
• \. Subject must agree to adhere to the follow-up schedule and study instructions.
• \. 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.
• \. 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.

You may not qualify if:

• 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.
• Subject had any prior invasive cosmetic surgery to the target area, such as liposuction
• Subject has scar tissue in and around the treatment area (i.e. cesarean-section or traumatic injury scar)
• Subject has tattoo(s) that extend over a substantial portion of the treatment area
• 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.
• Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
• Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
• History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
• History of any disease or condition that could impair wound healing.
• Infection, dermatitis, rash or other skin abnormality in the target area.
• History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing
• History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, and abdominal aortic aneurysm
• 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.
• History of skin disease in the treatment area or known epidermal or dermal disorders (particularly if involving collagen or microvascularity)
• Severe skin laxity in the treatment area

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (2)

Skincare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Dermatology and Laser Surgery Center of New York

New York, New York, 10028, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: May 29, 2020
• Study Start: December 2, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: June 1, 2022

Record last verified: 2020-02

Locations

US (2)