Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen
1 other identifier
interventional
40
1 country
1
Brief Summary
The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2018
CompletedApril 12, 2023
April 1, 2023
1 year
August 30, 2017
April 11, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.
4 months
Occurrence of adverse events
The occurrence of adverse events will be followed throughout the whole study.
7 months
Secondary Outcomes (5)
Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators
4 months
Efficacy of the BTL-899 treatment for abdomen circumference reduction
4 months
Ultrasound imaging
4 months
Subject's satisfaction with study treatment
4 months
Therapy comfort during the study treatment.
1 month
Study Arms (1)
BTL-899 Therapy Arm
EXPERIMENTALBTL-899 therapy, 3 therapies
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aesthe Clinic
Sofia, 1700, Bulgaria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2017
First Posted
September 1, 2017
Study Start
September 1, 2017
Primary Completion
September 19, 2018
Study Completion
October 3, 2018
Last Updated
April 12, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share