NCT03242564

Brief Summary

The purpose of this study is to determine whether red light therapy using LED 650nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2017

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

11 days

First QC Date

July 26, 2017

Last Update Submit

August 3, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost

    Circumferential measurement of thighs, hips and waist before and after treatment.

    One 28 minute treatment session.

Study Arms (1)

Active Device

EXPERIMENTAL

Active Device: Vevazz LED red light therapy system Vevazz LED red light therapy system is a treatment regimen using the Vevazz LED device for fat removal using LED red light therapy.

Device: Vevazz LED

Interventions

Vevazz LEDDEVICE

Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.

Active Device

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years or older.
  • May be male or female.
  • Generally good health.

You may not qualify if:

  • Minors.
  • Open wounds or sores.
  • Pacemaker.
  • Photosensitivity.
  • Epilepsy.
  • Any form of cancer.
  • Severe kidney or liver problems.
  • Thyroid problems.
  • Pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vevazz, LLC

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jamie Fettig

    Owner

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 8, 2017

Study Start

July 10, 2017

Primary Completion

July 21, 2017

Study Completion

July 21, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

No current plan to share data.

Locations

US(1)