Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04146467
Brief Summary:
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.
Detailed Description:
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device.
Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure.
Phase II (n=65) of this study is the expansion of the study to a pivotal study.
Study:
NCT04146467
Study Brief:
Protocol Section:
NCT04146467