Thighs Circumferential ReductionNCT02527369
Effect of the XP1100RF Therapy on Thighs Circumference Reduction
A study testing XP1100RF in people with Thighs Circumferential Reduction and Subcutaneous Fat Cell Disruption, run by BTL Industries Ltd..
Trial summary
This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thighs Circumferential Reduction, Subcutaneous Fat Cell Disruption
- What is being tested?
- XP1100RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Mar 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 22 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 thighs such as liposuction
- Medical, physical or other contraindications for body sculpting/ weight loss
Show all 13Show fewer
- 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
This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells.
Read the detailed description
This study is a prospective, single-arm, open label study of thighs circumference 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 in achieving thighs circumference reduction of ≥1 cm relative to the base line assessment.
- Being tested
- XP1100RF
- Keywords
- Fat Reduction, Lipolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP1100RFDevice
Treatment of adipose tissue within the fat layer with XP1100RF device.
| Study group | Role | What they receive |
|---|---|---|
| XP1100RF group | Experimental | Subjects in the XP1100RF group will be treated with the XP1100RF device. Receives: Device: XP1100RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thighs Circumference Reduction from Baseline at 30 days Follow Up
The primary efficacy outcome measure is set to be a minimum of 80% of subjects at 30-day follow up evaluation to show thighs circumference reduction of ≥1 cm below the gluteal fold relative to the base line assessment.
Measured: 30 days Follow Up
Secondary outcomes (3)
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: 30 days 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
Subject satisfaction assessed by questionnaires
Subject satisfaction as assessed by questionnaires administered at 30 days follow up.
Measured: 30 days Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thighs 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT02527369
- Sponsor's protocol ID
- Version1-713/2/2014
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2015
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the XP1100RF Therapy on Thighs Circumference Reduction
- ClinicalTrials.gov ID
- NCT02527369
- Acronym / sponsor ID
- Version1-713/2/2014
- Keywords
- Fat Reduction, Lipolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Aug 2015 (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 XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells.
Detailed description
This study is a prospective, single-arm, open label study of thighs circumference 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 in achieving thighs circumference reduction of ≥1 cm relative to the base line assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XP1100RF group | Experimental | Device: XP1100RFSubjects in the XP1100RF group will be treated with the XP1100RF device. |
Who may qualify
- Ages
- 22 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 thighs 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 |
|---|---|---|
| XP1100RFTreatment of adipose tissue within the fat layer with XP1100RF device. | Device | XP1100RF group |
Primary outcome
Thighs Circumference Reduction from Baseline at 30 days Follow Up
Time frame: 30 days Follow Up
The primary efficacy outcome measure is set to be a minimum of 80% of subjects at 30-day follow up evaluation to show thighs circumference reduction of ≥1 cm below the gluteal fold relative to the base line assessment.
3 secondary outcomes
Adverse Events
Time frame: 30 days Follow Up
Adverse Events
Time frame: 3 months Follow Up
Subject satisfaction assessed by questionnaires
Time frame: 30 days 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 13 Jul 2020.
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 XP1100RF in people with Thighs Circumferential Reduction and Subcutaneous Fat Cell Disruption, 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 13 Jul 2020. 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. 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?
Thighs Circumference Reduction from Baseline at 30 days Follow Up (time frame: 30 days Follow Up). 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 13 Jul 2020.