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This is a prospective, in vivo proof-of-concept clinical study, where histopathologic examinations will be conducted at various timepoints following Bellafill injections.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bellafill 1 week post-injection | n=2. Histopathology conducted 1 week post-injection |
| |
| Bellafill 1 month post-injection | n=2. Histopathology conducted 1 month post-injection |
| |
| Bellafill 2 months post-injection | n=2. Histopathology conducted 2 months post-injection |
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| Bellafill 3 months post-injection | n=2. Histopathology conducted 3 months post-injection |
| |
| Bellafill 6 months post-injection | n=2. Histopathology conducted 6 months post-injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bellafill | Device | Bellafill injected into site of pre-planned surgery (i.e., mini-abdominoplasty or redundant abdominal tissue removal) at two depths (dermis & deep dermis). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histopathology | Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue. | 1 week |
| Histopathology | Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue. | 1 month |
| Histopathology | Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue. | 2 months |
| Histopathology | Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue. | 3 months |
| Histopathology | Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Male and Female
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Seretta | Suneva Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call Suneva for Info | Danville | California | 94506 | United States |
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Tissue Pathology