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出境医 / 临床实验 / Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

Study Description
Brief Summary:
The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits

Condition or disease Intervention/treatment Phase
Improvement of Abdomen Appearance Device: BTL-899 Device: Sham Not Applicable

Detailed Description:
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : December 3, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: BTL-899 Therapy Arm Device: BTL-899
Treatment with BTL-899 device, 3 therapies
Sham Comparator: Sham Arm Device: Sham
Sham treatment with BTL-899 device, 3 visits
Outcome Measures
Primary Outcome Measures :
  1. Efficacy of the BTL-899 treatment for change in abdominal circumference [ Time Frame: 4 months ]
    Comparison of change in abdominal circumference at the final follow-up visit between two study groups.

  2. Occurrence of adverse events [ Time Frame: 7 months ]
    The occurrence of adverse events will be followed throughout the whole study.


Secondary Outcome Measures :
  1. Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators [ Time Frame: 4 months ]
    Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment.

  2. Efficacy of the BTL-899 treatment for change in abdominal circumference [ Time Frame: 4 months ]
    Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups.

  3. Efficacy of the BTL-899 treatment for abdominal fat reduction [ Time Frame: 4 months ]
    Comparison of fat reduction between two study groups using ultrasound images.

  4. Subject's satisfaction with study treatment [ Time Frame: 4 months ]
    Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).

  5. Therapy comfort during the study treatment. [ Time Frame: 1 month ]
    Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 21 years
  • Voluntarily signed informed consent form
  • BMI ≤ 35 kg/m2
  • Women of child-bearing potential are required to use birth control measures during the whole duration of the study
  • Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring 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

Exclusion Criteria:

  • Cardiac pacemakers
  • Cardiovascular diseases
  • Implanted defibrillators, implanted neurostimulators
  • Electronic implants
  • Disturbance of temperature or pain perception
  • Pulmonary insufficiency
  • Metal implants
  • Drug pumps
  • Malignant tumor
  • Hemorrhagic conditions
  • Septic conditions and empyema
  • Acute inflammations
  • Systemic or local infection such as osteomyelitis and tuberculosis
  • Contageous skin disease
  • Elevated body temperature
  • Pregnancy
  • Breastfeeding
  • Injured or otherwise impaired muscles
  • Scars, open lesions and wounds at the treatment area
  • Basedow's disease
  • Previous liposuction in the treatment area in the last six months
  • Abdominal wall diastasis
  • Unstable weight within the last 6 months
  • Previous body contouring treatments in the abdomen area in the last three months
Contacts and Locations

Locations
Layout table for location information
Bulgaria
Dr-Denkova Dermatology
Sofia, Bulgaria, 1700
Sponsors and Collaborators
BTL Industries Ltd.
Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE December 3, 2018
Estimated Primary Completion Date December 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Efficacy of the BTL-899 treatment for change in abdominal circumference [ Time Frame: 4 months ]
    Comparison of change in abdominal circumference at the final follow-up visit between two study groups.
  • Occurrence of adverse events [ Time Frame: 7 months ]
    The occurrence of adverse events will be followed throughout the whole study.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators [ Time Frame: 4 months ]
    Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment.
  • Efficacy of the BTL-899 treatment for change in abdominal circumference [ Time Frame: 4 months ]
    Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups.
  • Efficacy of the BTL-899 treatment for abdominal fat reduction [ Time Frame: 4 months ]
    Comparison of fat reduction between two study groups using ultrasound images.
  • Subject's satisfaction with study treatment [ Time Frame: 4 months ]
    Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).
  • Therapy comfort during the study treatment. [ Time Frame: 1 month ]
    Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment
Official Title  ICMJE Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment
Brief Summary The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits
Detailed Description This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Improvement of Abdomen Appearance
Intervention  ICMJE
  • Device: BTL-899
    Treatment with BTL-899 device, 3 therapies
  • Device: Sham
    Sham treatment with BTL-899 device, 3 visits
Study Arms  ICMJE
  • Experimental: BTL-899 Therapy Arm
    Intervention: Device: BTL-899
  • Sham Comparator: Sham Arm
    Intervention: Device: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 26, 2019) 		60
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 21 years
  • Voluntarily signed informed consent form
  • BMI ≤ 35 kg/m2
  • Women of child-bearing potential are required to use birth control measures during the whole duration of the study
  • Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring 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

Exclusion Criteria:

  • Cardiac pacemakers
  • Cardiovascular diseases
  • Implanted defibrillators, implanted neurostimulators
  • Electronic implants
  • Disturbance of temperature or pain perception
  • Pulmonary insufficiency
  • Metal implants
  • Drug pumps
  • Malignant tumor
  • Hemorrhagic conditions
  • Septic conditions and empyema
  • Acute inflammations
  • Systemic or local infection such as osteomyelitis and tuberculosis
  • Contageous skin disease
  • Elevated body temperature
  • Pregnancy
  • Breastfeeding
  • Injured or otherwise impaired muscles
  • Scars, open lesions and wounds at the treatment area
  • Basedow's disease
  • Previous liposuction in the treatment area in the last six months
  • Abdominal wall diastasis
  • Unstable weight within the last 6 months
  • Previous body contouring treatments in the abdomen area in the last three months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000945
Other Study ID Numbers  ICMJE BTL-899S
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BTL Industries Ltd.
Study Sponsor  ICMJE BTL Industries Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BTL Industries Ltd.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP