Fat DisorderNCT03898830
Eon™ FR Clinical Study Protocol 1064
A study testing eon™ FR 1064 nm device in people with Fat Disorder, run by Dominion Aesthetic Technologies, Inc. at 3 sites in United States.
Trial summary
This study evaluates the treatment of subjects with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Disorder
- What is being tested?
- eon™ FR 1064 nm device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Dec 2018to 22 Mar 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 30 kg/m2 or less.
- Healthy male or female between the ages of 21 and 60.
- Had, at least 25 mm thickness adipose tissue on abdomen.
- Able to read, understand and sign the Informed Consent Form (ICF).
- Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- Willing to have limited sun exposure for the duration of the study, including the follow-up period.
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- Willing to have photographs and ultrasound measurements taken of the treated area, which could be used de-identified in evaluations and could be used de-identified in presentations and/or publications.
- Female subjects were either post-menopausal, surgically sterilized, or used a medically acceptable form of birth control during the entire course of the study.
- Female subjects with child bearing potential were willing to take a urine pregnancy test and the result must be negative.
- Agreed to maintain their current diet and exercise habits and not be specifically trying to lose weight.
Who cannot join
- Aesthetic fat reduction procedure in the treatment area within the previous year.
- Age less than 21 or greater than 60 years old.
- Female subject pregnant or planning to become pregnant during the study duration,
- Had an infection, dermatitis or a rash in the treatment area.
- Had tattoos or jewelry in the treatment area.
- Had a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
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- Had a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- Had a history of a known bleeding disorder.
- Had a known photosensitivity to the study laser wavelength, history of ingesting. medications known to induce photosensitivity, or history of seizure disorders due to light.
- Had known collagen, vascular disease or scleroderma.
- Underwent a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
- Had underwent a fat reduction procedure in the treatment area within the past 12 months.
- Had a significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
- Underwent systemic chemotherapy for the treatment of cancer.
- Used gold therapy for disorders such as rheumatologic disease or lupus.
- 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 had any physical or mental condition which might make it unsafe for the subject to participate in this study.
- Concurrent use of steroids or secondary rheumatoid drugs.
- Prior liposuction or a tummy tuck in the study area.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fiala Aesthetics
Altamonte Springs, Florida, 32701
Miami Dermatology & Laser Research
Miami, Florida, 33173
Laser & Skin Surgery Center of Northern
Sacramento, California, 95816
About this study
Official title: A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single-arm Evaluation of the Eon™ FR 1064 nm Device to Reduce Abdominal Fat With a 12-week Observation Interval to Assess Safe Fat Reduction
This study evaluates the treatment of subjects with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue.
Read the detailed description
This study evaluates the treatment of subjects between 18-60 with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue in the abdomen.
- Conditions
- Fat Disorder
- Being tested
- eon™ FR 1064 nm device
- Keywords
- Adipose tissue, abdominal
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eon™ FR 1064 nm deviceDevice
The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
| Study group | Role | What they receive |
|---|---|---|
| eon™ FR 1064 nm device | Experimental | Patient will be treated with the eon™ FR 1064 nm device Receives: Device: eon™ 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 (3)
Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness
Circumferential measurements of the treatment area will be completed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness.
Measured: 12 weeks
Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness
Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness.
Measured: 12 weeks
Subject Questionnaire to determine 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 posted2 Apr 2019
- Study start8 Dec 2018
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat DisorderStudies 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
- 36 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
- NCT03898830
- Sponsor's protocol ID
- D0000000135
- Status last verified
- May 2020
- First submitted
- 28 Mar 2019
- Last updated
- 19 May 2020
- 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 19 May 2020. 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 Eon™ FR 1064 nm Device to Reduce Abdominal Fat With a 12-week Observation Interval to Assess Safe Fat Reduction
- ClinicalTrials.gov ID
- NCT03898830
- Acronym / sponsor ID
- D0000000135
- Conditions
- Fat Disorder
- Keywords
- Adipose tissue, abdominal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dominion Aesthetic Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2018 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 2 Apr 2019 (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 study evaluates the treatment of subjects with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue.
Detailed description
This study evaluates the treatment of subjects between 18-60 with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue in the abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eon™ FR 1064 nm device | Experimental | Device: eon™ FR 1064 nm devicePatient will be treated with the eon™ FR 1064 nm device |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Body Mass Index (BMI) of 30 kg/m2 or less.
- Healthy male or female between the ages of 21 and 60.
- Had, at least 25 mm thickness adipose tissue on abdomen.
- Able to read, understand and sign the Informed Consent Form (ICF).
- Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
Key exclusion criteria (19 listed)
- Aesthetic fat reduction procedure in the treatment area within the previous year.
- Age less than 21 or greater than 60 years old.
- Female subject pregnant or planning to become pregnant during the study duration,
- Had an infection, dermatitis or a rash in the treatment area.
- Had tattoos or jewelry in the treatment area.
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 |
|---|---|---|
| eon™ FR 1064 nm deviceThe subject treatment area - abdomen, was treated with the 1064 nm wavelength laser. | Device | eon™ FR 1064 nm device |
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.
3 secondary outcomes
Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness
Time frame: 12 weeks
Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness
Time frame: 12 weeks
Subject Questionnaire to determine 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 19 May 2020.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eon™ FR 1064 nm device in people with Fat Disorder, run by Dominion Aesthetic Technologies, Inc. at 3 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 10 inclusion and 19 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 19 May 2020.