Reduction of the Waist CircumferenceREDUCENCT02187237
Safety and Effectiveness of the "YOLO TOUCH" LLLT for Circumference Reduction of the Waistline
A study testing YOLO TOUCH Low Level Laser in people with Reduction of the Waist Circumference, run by Yolo Medical Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reduction of the Waist Circumference
- What is being tested?
- YOLO TOUCH Low Level Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Burnett Sports Performance Center
McMurray, Pennsylvania, 15317
About this study
Official title: A RandomizEd DoUble Blinded Controlled Study to Evaluate the Safety and Effectiveness of the "YOLO TOUCH" Low Level Laser Therapy (LLLT) for Circumference Reduction of he Waistline - REDUCE
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.
Read the 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.
- Conditions
- Reduction of the Waist Circumference
- Being tested
- YOLO TOUCH Low Level Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YOLO TOUCH Low Level LaserDevice
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy | Experimental | Not described Receives: Device: YOLO TOUCH Low Level Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (1)
Complications, device related adverse events during LLLT and device related adverse events post LLLT.
Measured: up to at day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of the Waist CircumferenceStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yolo Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Portz, M.D., Principal investigator, Burnett Sports Perfomance Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187237
- Sponsor's protocol ID
- YTCSP-2013-YOLO-REDUCE
- Acronym
- REDUCE
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RandomizEd DoUble Blinded Controlled Study to Evaluate the Safety and Effectiveness of the "YOLO TOUCH" Low Level Laser Therapy (LLLT) for Circumference Reduction of he Waistline - REDUCE
- ClinicalTrials.gov ID
- NCT02187237
- Acronym / sponsor ID
- REDUCE / YTCSP-2013-YOLO-REDUCE
- Conditions
- Reduction of the Waist Circumference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yolo Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Jul 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser therapy | Experimental | Device: YOLO TOUCH Low Level Laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| YOLO TOUCH Low Level Laser | Device | Laser therapy |
Primary outcome
Reduction of girth measurements for the waistline
Time frame: 3 weeks
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.
1 secondary outcome
Complications, device related adverse events during LLLT and device related adverse events post LLLT.
Time frame: up to at day 50
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 Jul 2014.
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.
Matthew Portz, M.D. principal investigator
Burnett Sports Perfomance Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YOLO TOUCH Low Level Laser in people with Reduction of the Waist Circumference, run by Yolo Medical 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 7 inclusion and 10 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 Jul 2014. 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?
Reduction of girth measurements for the waistline (time frame: 3 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 10 Jul 2014.