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出境医 / 临床实验 / Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue

Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue

Study Description
Brief Summary:
The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.

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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : September 17, 2019
Actual Study Completion Date : October 7, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: BTL-899 Therapy Arm Device: BTL-899
BTL-899 therapy
Outcome Measures
Primary Outcome Measures :
  1. Histology Examination [ Time Frame: 4 months ]
    Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure

  2. Evaluation of Satefy: Occurence of adverse events throughout the study [ Time Frame: 4 months ]
    Following the occurence of adverse events throughout the study.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age above 21 years and below 60 years
  • Voluntarily signing of the informed consent form
  • Women of child-bearing potential are required to use birth control measures during the whole duration of the study
  • Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
  • Subjects willing and able to abstain from partaking in any 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:

  • Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
  • Cardiovascular diseases
  • 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
  • Contagious 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 (change in weight ± 3%)
  • Previous body contouring treatments in the abdomen area in the last three months
  • Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion
  • Any disease or condition that may compromise the histologic observation at the pathologist discretion
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 April 18, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date September 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Histology Examination [ Time Frame: 4 months ]
    Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure
  • Evaluation of Satefy: Occurence of adverse events throughout the study [ Time Frame: 4 months ]
    Following the occurence of adverse events throughout the study.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Histology Examination [ Time Frame: 4 months ]
    Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure
  • Evaluation of satefy: occurence of adverse events througout the study [ Time Frame: 4 months ]
    Following the occurence of adverse events througout the study.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
Official Title  ICMJE Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
Brief Summary The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Improvement of Abdomen Appearance
Intervention  ICMJE Device: BTL-899
BTL-899 therapy
Study Arms  ICMJE Experimental: BTL-899 Therapy Arm
Intervention: Device: BTL-899
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2019) 		8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 7, 2019
Actual Primary Completion Date September 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age above 21 years and below 60 years
  • Voluntarily signing of the informed consent form
  • Women of child-bearing potential are required to use birth control measures during the whole duration of the study
  • Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
  • Subjects willing and able to abstain from partaking in any 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:

  • Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
  • Cardiovascular diseases
  • 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
  • Contagious 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 (change in weight ± 3%)
  • Previous body contouring treatments in the abdomen area in the last three months
  • Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion
  • Any disease or condition that may compromise the histologic observation at the pathologist discretion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (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 NCT03923855
Other Study ID Numbers  ICMJE 899-H1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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 December 2019

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