---
title: Eon™ FR 1064 Full Abdomen Clinical Study Protocol
nct_id: NCT04842110
overall_status: COMPLETED
phase: NA
sponsor: Dominion Aesthetic Technologies, Inc.
study_type: INTERVENTIONAL
primary_condition: Abdominal Obesity
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04842110.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04842110"
ct_last_update_post_date: 2021-04-13
last_seen_at: "2026-05-12T06:07:25.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Eon™ FR 1064 Full Abdomen Clinical Study Protocol

**Official Title:** A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat

**NCT ID:** [NCT04842110](https://clinicaltrials.gov/study/NCT04842110)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 26
- **Lead Sponsor:** Dominion Aesthetic Technologies, Inc.
- **Conditions:** Abdominal Obesity
- **Start Date:** 2019-08-24
- **Completion Date:** 2019-12-21
- **CT.gov Last Update:** 2021-04-13

## Brief 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. This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.
```

## Arms

- **1064 Full Abdomen** (EXPERIMENTAL) — eonTM FR 1064 nm device Patient will be treated with the eonTM FR 1064 nm device

## Interventions

- **Experimental: eonTM FR 1064 nm device** (DEVICE) — The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Change in Adipose Layer Thickness** _(time frame: 12 weeks)_
- **Subject Satisfaction** _(time frame: 12 weeks)_

## Locations (1)

- Fiala Aesthetics, Altamonte Springs, Florida, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fiala aesthetics|altamonte springs|florida|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04842110*  
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