Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541899
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Safety and Efficacy of Cryolipolysis Clinical Protocols
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Cryolipolysis Clinical Protocols
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single-arm multicenter interventional clinical study will be conducted The objective is to evaluate the safety and efficacy of the cryolipolysis technique Approximately 372 participants will be included After analyzing the items listed above the participants in each study will be divided into 3 distinct intervention groups The individuals included in the study will undergo anamnesis and data collection
Detailed Description:
The participants in each study will be divided into 3 distinct intervention groups Grupo 1 aplicador 360 M - Região abdominal Grupo 2 aplicador 360 G - Região abdominal Grupo 3 aplicador de placas - Região dos flancos After analyzing the inclusion and exclusion criteria of this study the individuals included in the study will undergo anamnesis and data collection after the procedure and 6 weeks and 20 weeks after photographic capture bioimpedance perimetry adipometry and ultrasound imaging of the treated area in addition to a pain and patient satisfaction questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None