Circumferential ReductionNCT02023385
BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction
A study testing BTL-9000 LLLT in people with Circumferential Reduction and Waist Circumferential Reduction, run by BTL Industries Ltd..
Trial summary
Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving 3 cm or greater average waist circumferential reduction in LLLT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumferential Reduction, Waist Circumferential Reduction
- What is being tested?
- BTL-9000 LLLT
- 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
- Sep 2013to Dec 2013
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 18-70 years of age of both gender with excess adipose tissue in the abdomen area
- Body Mass Index (BMI) of 25 to 35 kg/m2.
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
- Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation.
Who cannot join
- Diabetics dependent on insulin or oral hypoglycemic medications
- Known cardiovascular disease such as arrhythmias, congestive heart failure
- Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- Prior surgical interventions for body sculpting of abdomen such as liposuction
- Medical, physical or other contraindications for body sculpting/ weight loss
- Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
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- Any medical condition known to affect weight levels and/or to cause bloating or swelling
- Active infection, wound or other external trauma to the area to be treated
- Pregnant, breast feeding, or planning pregnant before the end of the study
- Serious mental health illness
- Photosensitivity disorder to 660 nm light
- Active or recurrent cancer or current chemotherapy and/or radiation treatment
About this study
Official title: Evaluation of the BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction
Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving 3 cm or greater average waist circumferential reduction in LLLT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.
Read the detailed description
Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the LLLT group of 25 subjects who are treated with the BTL-9000 LLLT and the other arm is the Placebo group of 15 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 LLLT treatment in achieving average post-treatment waist circumferential reduction of 3 cm or greater across the waistline relative to the baseline assessment and of 1 cm or greater than the average waist circumferential reduction of the Placebo group.
- Being tested
- BTL-9000 LLLT, sham BTL-9000 LLLT
- Keywords
- Low Level Laser Therapy, LLLT, Waist circumferential reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-9000 LLLTDevice
Also called BTL-9000 LowLevel Laser Therapy
Irradiation of adipocyte cells within the fat layer with BTL-9000 LLLT for the release of fat and lipids from these cells
sham BTL-9000 LLLTDevice
Irradiation of adipocyte cells within the fat layer with sham BTL-9000 LLLT for the release of fat and lipids from these cells
| Study group | Role | What they receive |
|---|---|---|
| LLLT group | Experimental | Subjects in the Low Level Laser Therapy (LLLT) group will be treated with the BTL-9000 LLLT Receives: Device: BTL-9000 LLLT |
| Placebo group | Placebo comparator | Subjects in the Placebo group with be treated with the sham BTL-9000 LLLT Receives: Device: sham BTL-9000 LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumferential reduction
The subjects in the LLLT group whose average post-treatment waist circumference shows reduction of 3 cm or greater across the waistline relative to the base line assessment and their average waist circumferential reduction is 1 cm or greater than the average circumferential reduction of Placebo group are considered to meet the study primary outcome success criteria.
Measured: 30 days follow up after 8 twice-a-week treatments
Secondary outcomes (1)
Adverse Events
Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits
Measured: 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumferential ReductionStudies 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, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Radina Denkova, MD, Principal investigator, Dermatologic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023385
- Sponsor's protocol ID
- BTL-9000 LLLT
- Status last verified
- Dec 2013
- First submitted
- 20 Dec 2013
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction
- ClinicalTrials.gov ID
- NCT02023385
- Acronym / sponsor ID
- BTL-9000 LLLT
- Keywords
- Low Level Laser Therapy, LLLT, Waist circumferential reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Dec 2013 (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.
Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving 3 cm or greater average waist circumferential reduction in LLLT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.
Detailed description
Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the LLLT group of 25 subjects who are treated with the BTL-9000 LLLT and the other arm is the Placebo group of 15 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 LLLT treatment in achieving average post-treatment waist circumferential reduction of 3 cm or greater across the waistline relative to the baseline assessment and of 1 cm or greater than the average waist circumferential reduction of the Placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLLT group | Experimental | Device: BTL-9000 LLLTSubjects in the Low Level Laser Therapy (LLLT) group will be treated with the BTL-9000 LLLT |
| Placebo group | Placebo comparator | Device: sham BTL-9000 LLLTSubjects in the Placebo group with be treated with the sham BTL-9000 LLLT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects 18-70 years of age of both gender with excess adipose tissue in the abdomen area
Key exclusion criteria (12 listed)
- Diabetics dependent on insulin or oral hypoglycemic medications
- Known cardiovascular disease such as arrhythmias, congestive heart failure
- Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- Prior surgical interventions for body sculpting of abdomen such as liposuction
- Medical, physical or other contraindications for body sculpting/ weight loss
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 |
|---|---|---|
| BTL-9000 LLLTAlso: BTL-9000 LowLevel Laser TherapyIrradiation of adipocyte cells within the fat layer with BTL-9000 LLLT for the release of fat and lipids from these cells | Device | LLLT group |
| sham BTL-9000 LLLTIrradiation of adipocyte cells within the fat layer with sham BTL-9000 LLLT for the release of fat and lipids from these cells | Device | Placebo group |
Primary outcome
Waist Circumferential reduction
Time frame: 30 days follow up after 8 twice-a-week treatments
The subjects in the LLLT group whose average post-treatment waist circumference shows reduction of 3 cm or greater across the waistline relative to the base line assessment and their average waist circumferential reduction is 1 cm or greater than the average circumferential reduction of Placebo group are considered to meet the study primary outcome success criteria.
1 secondary outcome
Adverse Events
Time frame: 1 month follow up
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 19 Sep 2014.
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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.
Radina Denkova, MD principal investigator
Dermatologic Clinic
Questions about this trial
What is this clinical trial studying?
A study testing BTL-9000 LLLT in people with Circumferential Reduction and Waist Circumferential Reduction, run by BTL Industries Ltd..
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 4 inclusion and 12 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 19 Sep 2014. 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?
Waist Circumferential reduction (time frame: 30 days follow up after 8 twice-a-week treatments). 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 19 Sep 2014.