Circumferential ReductionNCT04406935
Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction
A study testing treatment with the study device (NuEra) in people with Circumferential Reduction, run by Lumenis Be Ltd. at 2 sites in United States.
Trial summary
Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumferential Reduction
- What is being tested?
- treatment with the study device (NuEra)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Dec 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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
- Extensive collection of visceral adipose tissue or abdominal wall diastasis or hernia on physical examination
- Obesity ≥30 BMI
- Diagnosed or documented immune system disorders.
- Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
- Participation in a clinical trial of another device or drug within 6 months of study participation, or during the study period.
- Pregnant or currently breastfeeding.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
- Known allergy to general and/or topical anesthetic
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Skincare Physicians
Chestnut Hill, Massachusetts, 02467
Dermatology and Laser Surgery Center of New York
New York, New York, 10028
About this study
Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group
Read the 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.
- Conditions
- Circumferential Reduction
- Being tested
- treatment with the study device (NuEra)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 475 KHz | Active comparator | NuEra device treatment using 475 KHz Receives: Device: treatment with the study device (NuEra) |
| 1 MHz | Active comparator | Arm 2: NuEra device treatment using 1 MHz Receives: Device: treatment with the study device (NuEra) |
| 2 MHz | Active comparator | NuEra device treatment using 2 MHz Receives: Device: treatment with the study device (NuEra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in abdominal circumference
Change in abdominal circumference in cm
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start2 Dec 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumferential ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406935
- Sponsor's protocol ID
- NuEra Tight-19-01
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction
- ClinicalTrials.gov ID
- NCT04406935
- Acronym / sponsor ID
- NuEra Tight-19-01
- Conditions
- Circumferential Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 475 KHz | Active comparator | Device: treatment with the study device (NuEra)NuEra device treatment using 475 KHz |
| 1 MHz | Active comparator | Device: treatment with the study device (NuEra)Arm 2: NuEra device treatment using 1 MHz |
| 2 MHz | Active comparator | Device: treatment with the study device (NuEra)NuEra device treatment using 2 MHz |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | 1 MHz, 2 MHz, 475 KHz |
Primary outcome
Reduction in abdominal circumference
Time frame: one month
Change in abdominal circumference in cm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Circumferential Reduction
Active, not recruiting
Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence
Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment with the study device (NuEra) in people with Circumferential Reduction, run by Lumenis Be Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in abdominal circumference (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.