Injury to Subcutaneous TissueNCT02909790
Study Safety and Effectiveness of CURVE Laser Therapy for Circumference Reduction of the Waistline.
A study testing Curve Low Level Laser Therapy in people with Injury to Subcutaneous Tissue, run by Yolo Medical Inc..
Trial summary
The purpose of this study is to assess the safety and effectiveness of the CURVE Low-Level Laser Therapy for circumference reduction of the waistline. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Injury to Subcutaneous Tissue
- What is being tested?
- Curve Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Sep 2016
- 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 64 years
- All sexes
- No healthy volunteers
- 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 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 of 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.
About this study
Official title: A RandomizEd DoUble Blinded ControllEd Study to Evaluate the Safety and Effectiveness of the CURVE Low Level Laser Therapy (LLLT) for Circumference Reduction of the Waistline.
The purpose of this study is to assess the safety and effectiveness of the CURVE Low-Level Laser Therapy for circumference reduction of the waistline.
Read the detailed description
This study involves research to obtain information on the CURVE. In recent years Low Level Laser therapy devices have grown in popularity due to increased scientific understanding of their mechanism of action, published research, and patients demand for more non-invasive procedures in body contour and fat reduction. LLL are widely used in health clinics, medical spas and in aesthetic medicine in the treatment of cellulite and for inflammatory conditions such as carpal tunnel syndrome. This study will further evaluate the effectiveness of low-level laser treatments without the extraction of adipose tissue using liposuction or in combination with other treatment modalities.
- Conditions
- Injury to Subcutaneous Tissue
- Being tested
- Curve Low Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curve Low Level Laser TherapyDevice
Subjects assigned to the treatment group will be treated with 4 multi-paddle low-level diode laser consisting of 8 independent diode laser heads per treatment paddle, each emitting 630-680nm (red) laser light with each diode generating 40mW output ("CURVE" Laser - manufactured by YOLO Medical Inc.).
| Study group | Role | What they receive |
|---|---|---|
| CURVE LLLT treatment | Experimental | Up to 20 subjects are randomly selected to receive Curve Low Level Laser Therapy Receives: Device: Curve Low Level Laser Therapy |
| SHAM device treatment | Sham comparator | Up to 20 subjects assigned to the sham group will be treated with a device that is designed to have the same physical appearance as the treatment group, except that the interlock fuse (grey fuse holder back of device) will be removed prior to treatment. The laser screen will still be active and show to the subject that the treatment time will still be counting down, but will not activate lasers in the treatment paddles Receives: Device: Curve Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of girth measurements for the waistline after successful completion of the three (3) week study procedure.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury to Subcutaneous 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yolo Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haneef Alibhai, MD, Principal investigator, UBC Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909790
- Sponsor's protocol ID
- CCSP-2016- CURVE
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2016
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. 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 CURVE Low Level Laser Therapy (LLLT) for Circumference Reduction of the Waistline.
- ClinicalTrials.gov ID
- NCT02909790
- Acronym / sponsor ID
- CCSP-2016- CURVE
- Conditions
- Injury to Subcutaneous Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yolo Medical Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Sep 2016 (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 purpose of this study is to assess the safety and effectiveness of the CURVE Low-Level Laser Therapy for circumference reduction of the waistline.
Detailed description
This study involves research to obtain information on the CURVE. In recent years Low Level Laser therapy devices have grown in popularity due to increased scientific understanding of their mechanism of action, published research, and patients demand for more non-invasive procedures in body contour and fat reduction. LLL are widely used in health clinics, medical spas and in aesthetic medicine in the treatment of cellulite and for inflammatory conditions such as carpal tunnel syndrome. This study will further evaluate the effectiveness of low-level laser treatments without the extraction of adipose tissue using liposuction or in combination with other treatment modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CURVE LLLT treatment | Experimental | Device: Curve Low Level Laser TherapyUp to 20 subjects are randomly selected to receive Curve Low Level Laser Therapy |
| SHAM device treatment | Sham comparator | Device: Curve Low Level Laser TherapyUp to 20 subjects assigned to the sham group will be treated with a device that is designed to have the same physical appearance as the treatment group, except that the interlock fuse (grey fuse holder back of device) will be removed prior to treatment. The laser screen will still be active and show to the subject that the treatment time will still be counting down, but will not activate lasers in the treatment paddles |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 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 |
|---|---|---|
| Curve Low Level Laser TherapySubjects assigned to the treatment group will be treated with 4 multi-paddle low-level diode laser consisting of 8 independent diode laser heads per treatment paddle, each emitting 630-680nm (red) laser light with each diode generating 40mW output ("CURVE" Laser - manufactured by YOLO Medical Inc.). | Device | CURVE LLLT treatment, SHAM device treatment |
Primary outcome
Reduction of girth measurements for the waistline after successful completion of the three (3) week study procedure.
Time frame: 3 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 26 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Injury to Subcutaneous Tissue
Recruiting
A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
Non-Healing Ulcer of Skin, Non-healing Wound
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.
Haneef Alibhai, MD principal investigator
UBC Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Curve Low Level Laser Therapy in people with Injury to Subcutaneous Tissue, run by Yolo Medical Inc..
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 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 after successful completion of the three (3) week study procedure. (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 26 Sep 2016.