NCT03923855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

April 18, 2019

Last Update Submit

December 18, 2019

Conditions

Improvement of Abdomen Appearance

Outcome Measures

Primary Outcomes (2)

  • Histology Examination

    Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure

    4 months

  • Evaluation of Satefy: Occurence of adverse events throughout the study

    Following the occurence of adverse events throughout the study.

    4 months

Study Arms (1)

BTL-899 Therapy Arm

EXPERIMENTAL
Device: BTL-899

Interventions

BTL-899DEVICE

BTL-899 therapy

BTL-899 Therapy Arm

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Denkova Dermatology

Sofia, 1700, Bulgaria

Location

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

April 18, 2019

First Posted

April 23, 2019

Study Start

May 1, 2019

Primary Completion

September 17, 2019

Study Completion

October 7, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Locations

BU(1)