Safety and Effectiveness of the "YOLO TOUCH" LLLT for Cir... | NCT02187237

Studies
Safety and Effectiveness of the "YOLO TOUCH" LLLT for Circumference Reduction of the Waistline

NCT02187237

Sponsor

Yolo Medical Inc.

Status

Completed

Last Update Posted

Jul 10, 2014Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Reduction of the Waist Circumference

Interventions

YOLO TOUCH Low Level Laser

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jul 8, 2014

First Submission Date that Met QC Criteria

Jul 9, 2014

First Posted Date

Jul 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2014

Last Update Posted Date

Jul 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area that emit laser light to reduce the circumference waistline.

Detailed Description

The YOLO TOUCH device is class II device intended for use in circumference reduction of the waist as a non-invasive, non-thermal, and low energy laser. Typical area of the body for use with the YOLO TOUCH is the abdominal area.

The YOLO TOUCH low-level therapy device consists of a main console and 8 multi-probes that are constructed so that each probe contains 12 laser emission diode sources at a power output of 35mW per diode.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Laser therapy	Experimental		Device: YOLO TOUCH Low Level Laser

Name	Type	Description	Arm Group Labels	Other Names
YOLO TOUCH Low Level Laser	Device		Laser therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of girth measurements for the waistline	Reduction of one (1.0) inch of girth measurement in the average of three circumference measurements for the waistline from baseline to after completion of the three (3) week study procedure (i.e., after nine (9) twenty (20) minute laser treatments - three (3) per week for three (3) weeks.	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Complications, device related adverse events during LLLT and device related adverse events post LLLT.		up to at day 50

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is an adult ≥ 18 years old and <65 years of age
Subject has maintained a stable weight for the past 6 months (variation no greater than 10 lbs. from "usual weight")
Subject is willing to maintain current diet and exercise regimen for the duration of the study.
Subject is willing and able to provide written informed consent.
Subject is willing to return for all scheduled and required visits.
Subject is willing to comply with post-laser treatment cardiovascular exercise.
Subject is willing to comply with food and fluid requirements pre-treatment and post-treatment.

Exclusion Criteria:

Subject is on an active weight control regimen.
Subject has a pacemaker.
Subject has a history of epilepsy.
Subject has a history of any type of cancer, including skin cancer.
Subject had a prior surgical intervention for body sculpting/weight loss such as liposuction, abdominoplasty, gastroplasty, lap band surgery, etc.
Subject has a medical, physical, or other contraindications for body sculpting/weight loss.
Subject has an active infection, wound or other external trauma to the areas to be treated with the laser.
Subject is pregnant, breast feeding, or planning pregnancy prior to study end.
Subject is participating in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course o the study participation.
Subject is participating in another research study of a device, medication, biologic, or other agent within 30 days or could, in the opinion of the investigator, affect the results of this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Feb 7, 2017
Reset	Mar 27, 2017