NCT03327311

Histological Analysis of Bellafill Injected Tissue at Various Time Points

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Suneva Medical, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Histopathology

Interventions

Type	Name	Description
DEVICE	Bellafill	Bellafill injected into site of pre-planned surgery (i.e., mini-abdominoplasty or redundant abdominal tissue removal) at two depths (dermis \& deep dermis).

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2017-10-31
• Last updated: 2017-10-31

Locations

1 site across 1 country: United States