Circumferential ReductionNCT02271672
XP1000 RF Therapy on Waist Circumference Reduction
A study testing XP1000 RF in people with Circumferential Reduction and Waist Circumferential Reduction, run by BTL Industries Ltd..
Trial summary
This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive temporary reduction of waist circumference by disruption of adipocyte cells. 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?
- XP1000 RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jun 2015
- 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
- Body Mass Index (BMI) of 20 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
- Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
- 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
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- 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
- 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
- Active or recurrent cancer or current chemotherapy and/or radiation treatment
- Negative affection to heat
About this study
Official title: Effect of the XP1000 RF Therapy on Waist Circumference Reduction
This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive temporary reduction of waist circumference by disruption of adipocyte cells.
Read the detailed description
This study is a prospective, double-blinded, randomized, two-arm sham-controlled study of circumferential waist reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day and 90-day Follow Up in achieving waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of sham group.
- Being tested
- XP1000 RF, sham XP1000 RF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP1000 RFDevice
Treatment of adipose tissue within the fat layer with XP1000 RF.
sham XP1000 RFDevice
Treatment of adipose tissue within the fat layer with XP1000 RF.
| Study group | Role | What they receive |
|---|---|---|
| XP1000 RF group | Experimental | Subjects in the XP1000 RF group will be treated with the XP1000 RF device. Receives: Device: XP1000 RF |
| Sham group | Sham comparator | Subjects in the Sham group will be treated with the sham XP1000 RF device. Receives: Device: sham XP1000 RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumferential reduction
The primary efficacy outcome measure is set to be a minimum of 80% of subjects in the XP1000 RF group at 30-day follow up evaluation to show waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of Sham group.
Measured: 30 days follow follow up after 4 once-a-week treatments
Secondary outcomes (2)
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
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: 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionJun 2015
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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, Aesthe Beauty Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271672
- Sponsor's protocol ID
- XP1000RF
- Status last verified
- Jun 2015
- First submitted
- 20 Oct 2014
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the XP1000 RF Therapy on Waist Circumference Reduction
- ClinicalTrials.gov ID
- NCT02271672
- Acronym / sponsor ID
- XP1000RF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Oct 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.
This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive temporary reduction of waist circumference by disruption of adipocyte cells.
Detailed description
This study is a prospective, double-blinded, randomized, two-arm sham-controlled study of circumferential waist reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day and 90-day Follow Up in achieving waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XP1000 RF group | Experimental | Device: XP1000 RFSubjects in the XP1000 RF group will be treated with the XP1000 RF device. |
| Sham group | Sham comparator | Device: sham XP1000 RFSubjects in the Sham group will be treated with the sham XP1000 RF device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) of 20 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.
Key exclusion criteria (13 listed)
- Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
- 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
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 |
|---|---|---|
| XP1000 RFTreatment of adipose tissue within the fat layer with XP1000 RF. | Device | XP1000 RF group |
| sham XP1000 RFTreatment of adipose tissue within the fat layer with XP1000 RF. | Device | Sham group |
Primary outcome
Waist Circumferential reduction
Time frame: 30 days follow follow up after 4 once-a-week treatments
The primary efficacy outcome measure is set to be a minimum of 80% of subjects in the XP1000 RF group at 30-day follow up evaluation to show waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of Sham group.
2 secondary outcomes
Adverse Events
Time frame: 1 month follow up
Adverse Events
Time frame: 3 months 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 18 Jun 2015.
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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
Aesthe Beauty Clinic
Questions about this trial
What is this clinical trial studying?
A study testing XP1000 RF 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 3 inclusion and 13 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 18 Jun 2015. 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 follow up after 4 once-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 18 Jun 2015.