Histological Analysis of Bellafill Injected Tissue at Various Time Points

Histopathology Clinical Trial

Official title: Histological Analysis of Bellafill Injected Tissue at Various Time Points: A Proof of Concept Study

Status Completed

Clinical Trial Summary

This is a prospective, in vivo proof-of-concept clinical study, where histopathologic examinations will be conducted at various timepoints following Bellafill injections.

Clinical Trial Description

Visit 1 (day 0): Subjects with pre-planned surgical treatment (mini-abdominoplasty or redundant abdominal tissue removal) will be enrolled and will receive a Bellafill Skin Test.

Visit 2 (Day 28): Each subject receives treatment with Bellafill into 2 identified rectangular treatment areas within the pre-planned surgical area (0.1cc injected in the upper dermis and 0.1cc injected in the deep dermis at the subcutaneous junction).

Visit 3 (1 Week, 1 Month, or 2 Months; or, 3 Months or 6 Months): The timing of Visit 3 (the final study visit) is dependent on the subject's type of pre-planned surgery. Subjects who will undergo abdominoplasty will attend Visit 3 at 1 Week, 1 Month or 2 Months after Visit 2. Subjects who will undergo removal of redundant skin (i.e., dog ear) will attend Visit 3 at 3 Months or 6 Months after Visit 2. Following surgical removal of Bellafill injection sites, histopathologic analyses will be conducted. ;

Related Conditions & MeSH terms

• Histopathology

• NCT number: NCT03327311
• Study type: Observational
• Source: Suneva Medical, Inc.
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Completion date: April 2017