Adipose TissueNCT04797988

Eon® Flanks Safety Clinical Study Protocol

A study testing eon® FR 1064 nm device in people with Adipose Tissue, run by Dominion Aesthetic Technologies, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks. Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Adipose Tissue
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: 11 participants
Where: 1 siteUnited States
Study dates: 6 Feb 2021to 15 May 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 99 years
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 flanks.
Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English.
Subject has sufficient thickness (≥ 20 mm) of adipose tissue on the flanks area.
Subject must be willing and able to adhere to the treatment and follow-up visit schedule.
Subject is willing to have photographs and ultrasound measurements taken of the treated area.
Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, or surgically sterilized.

Who cannot join

• Subject had an aesthetic fat reduction procedure in the treatment area within the previous year
Subject was pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 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.
Subject has a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.

Show all 17Show fewer

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.

United States1 site

Fiala Aesthetics
Altamonte Springs, Florida, 32701

Other trials in United States

About this study

This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.

Read the detailed description

This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.

Conditions: Adipose Tissue
Being tested: eon® FR 1064 nm device

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 will be treatment area - flanks, will be treated with the eon device.

Study groups in NCT04797988
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.

Safety Evaluation eon® treatment of the flanks (Adverse Events)
Adverse Events will be assessed to include ultrasound evaluations with a single expert sonographer identifying the pre-treatment versus Week 2 post-treatment.
Measured: 2 weeks

Secondary outcomes (1)

Subject Satisfaction
Subject Questionnaires will be completed by subjects at the end of the study to determine subject satisfaction with the procedure. Subjects will respond using a scale of 1-6, with 1 being extremely satisfied and 6 being extremely dissatisfied.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 202115 May 2021

First posted15 Mar 2021
Study start6 Feb 2021
Primary completion15 May 2021
Study completion15 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Adipose TissueStudies 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: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04797988
Sponsor's protocol ID: D0000000160
Status last verified: Jun 2021
First submitted: 10 Mar 2021
Last updated: 10 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Fiala T, Lavin P. Safety of a 1064-nm robotic laser system for noninvasive lipolysis of the flanks. Lasers Surg Med. 2022 Jul;54(5):672-681. doi: 10.1002/lsm.23532. Epub 2022 Mar 9.
PubMed 35266172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adipose Tissue trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Eon® Flanks Safety Clinical Study Protocol
ClinicalTrials.gov ID: NCT04797988
Acronym / sponsor ID: D0000000160
Conditions: Adipose Tissue
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Dominion Aesthetic Technologies, Inc.Industry (pharma, biotech, devices)
Study start: 6 Feb 2021 (actual)
Primary completion: 15 May 2021 (actual)
Study completion: 15 May 2021 (actual)
First posted: 15 Mar 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 study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.

Detailed description

This study is designed to provide objective evidence regarding the safety of eon® treatment of the flanks.

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: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject is a healthy male or female > 18 years or older seeking treatment for unwanted fat in the flanks.

Key exclusion criteria (17 listed)

• Subject had an aesthetic fat reduction procedure in the treatment area within the previous year

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 will be treatment area - flanks, will be treated with the eon device.	Device	eon FR 1064 nm Device

Primary outcome

Safety Evaluation eon® treatment of the flanks (Adverse Events)
Time frame: 2 weeks
Adverse Events will be assessed to include ultrasound evaluations with a single expert sonographer identifying the pre-treatment versus Week 2 post-treatment.

1 secondary outcome

Subject Satisfaction
Time frame: 2 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 10 Jun 2021.
Derived from this study: PubMed 35266172Fiala T, Lavin P. Safety of a 1064-nm robotic laser system for noninvasive lipolysis of the flanks. Lasers Surg Med. 2022 Jul;54(5):672-681. doi: 10.1002/lsm.23532. Epub 2022 Mar 9.
Individual participant dataSharing planned: No

Related trials for Adipose Tissue

RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
RecruitingPhase 3
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Generalized Lipodystrophy
Active, not recruitingPhase 2
A Study of Etrumadenant and Zimberelimab in People With Dedifferentiated Liposarcoma
Dedifferentiated Liposarcoma, Soft Tissue Sarcoma

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 eon® FR 1064 nm device in people with Adipose Tissue, 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 6 inclusion and 17 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 10 Jun 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?

Safety Evaluation eon® treatment of the flanks (Adverse Events) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04797988, which also lists 1 linked publication.

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 10 Jun 2021.