Abdominal ObesityNCT04842110
Eon™ FR 1064 Full Abdomen Clinical Study Protocol
A study testing Experimental: eonTM FR 1064 nm device in people with Abdominal Obesity, run by Dominion Aesthetic Technologies, Inc. at 1 site in United States.
Trial summary
This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Experimental: eonTM FR 1064 nm device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2019to 21 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a healthy male or female > 18 years or older seeking treatment for unwanted fat in the abdomen.
- Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English.
- Subject has sufficient thickness (≥ 25 mm) of adipose tissue on the abdomen area.
- Study subjects must agree to maintain their current diet and weight (not gaining or losing greater than ±5 lbs.
- Subject must be willing and able to adhere to the treatment and follow-up visit schedule.
- Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period.
- Subject is willing to have photographs and ultrasound measurements taken of the treated area, which will be de-identified in evaluations and may be used in presentations and/or publications.
- Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, surgically sterilized.
Who cannot join
- Aesthetic fat reduction procedure in the treatment area within the previous year.
- Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 months
- Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
- Subject has an infection, dermatitis or a rash in the treatment area.
- Subject has tattoos or jewelry in the treatment area or within the treatment area site or photography frame.
- Subject has a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
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- Subject has a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- Subject has a history of a known bleeding disorder.
- Subject has a known photosensitivity to the study laser wavelength, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
- Subject has known collagen, vascular disease or scleroderma.
- Subject has undergone a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
- Subject suffers from significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
- Subject is undergoing systemic chemotherapy for the treatment of cancer.
- Subject is using gold therapy for disorders such as rheumatologic disease or lupus.
- Subject has participated in a study of another device or drug within three months prior to enrollment or during the study.
- As per the investigator's discretion, the subject has any physical or mental condition which might make it unsafe for the subject to participate in this study.
- Subject has ongoing use of steroids or secondary rheumatoid drugs.
- Subject is actively taking psychotropic medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat
This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.
- Conditions
- Abdominal Obesity
- Being tested
- Experimental: eonTM FR 1064 nm device
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: eonTM FR 1064 nm deviceDevice
The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
| Study group | Role | What they receive |
|---|---|---|
| 1064 Full Abdomen | Experimental | eonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device Receives: Device: Experimental: eonTM FR 1064 nm device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Evaluations as a Measure of Effectiveness
Photographs of the treatment area will be obtained at baseline and 12 weeks post treatment and be evaluated by blinded independent readers to correctly identify pre-treatment (baseline) photographs compared to 12 weeks post treatment photographs in order to determine effectiveness of device.
Measured: 12 Weeks
Secondary outcomes (2)
Change in Adipose Layer Thickness
Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both.
Measured: 12 weeks
Subject Satisfaction
Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start24 Aug 2019
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dominion Aesthetic Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842110
- Sponsor's protocol ID
- D0000000151
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat
- ClinicalTrials.gov ID
- NCT04842110
- Acronym / sponsor ID
- D0000000151
- Conditions
- Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dominion Aesthetic Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2019 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 13 Apr 2021 (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.
This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1064 Full Abdomen | Experimental | Device: Experimental: eonTM FR 1064 nm deviceeonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is a healthy male or female > 18 years or older seeking treatment for unwanted fat in the abdomen.
- Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English.
- Subject has sufficient thickness (≥ 25 mm) of adipose tissue on the abdomen area.
- Study subjects must agree to maintain their current diet and weight (not gaining or losing greater than ±5 lbs.
- Subject must be willing and able to adhere to the treatment and follow-up visit schedule.
Key exclusion criteria (18 listed)
- Aesthetic fat reduction procedure in the treatment area within the previous year.
- Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 months
- Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
- Subject has an infection, dermatitis or a rash in the treatment area.
- Subject has tattoos or jewelry in the treatment area or within the treatment area site or photography frame.
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 |
|---|---|---|
| Experimental: eonTM FR 1064 nm deviceThe subject treatment area - abdomen, was treated with the 1064 nm wavelength laser. | Device | 1064 Full Abdomen |
Primary outcome
Photographic Evaluations as a Measure of Effectiveness
Time frame: 12 Weeks
Photographs of the treatment area will be obtained at baseline and 12 weeks post treatment and be evaluated by blinded independent readers to correctly identify pre-treatment (baseline) photographs compared to 12 weeks post treatment photographs in order to determine effectiveness of device.
2 secondary outcomes
Change in Adipose Layer Thickness
Time frame: 12 weeks
Subject Satisfaction
Time frame: 12 weeks
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 13 Apr 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: eonTM FR 1064 nm device in people with Abdominal Obesity, run by Dominion Aesthetic Technologies, Inc. at 1 site 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 8 inclusion and 18 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Photographic Evaluations as a Measure of Effectiveness (time frame: 12 Weeks). 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 13 Apr 2021.