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The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study.
Safety endpoint: incidence of adverse events.
The objective of this study is to identify and assess tissue responses after injection with various biostimulatory products that are already used in the market and have CE approval. The study will assess in vivo tissue responses and provide tissue specimens which will be used in a subsequent study, under a separate protocol.
Assessments under this protocol will include ultrasound of in vivo tissue.
Safety endpoint: incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Subjects in Arm 1 will receive injections of biostimulatory products (Radiesse, Sculptra, Ellanse, HArmonyCa) at 3 timepoints (six months, three months and two weeks) prior to removal of redundant abdominal tissue. |
|
| Arm 2 | Experimental | Subjects in Arm 2 will receive injections of 1 of 2 selected biostimulatory products (Radiesse or Sculptra) at 1 timepoint (6 months) prior to removal of redundant abdominal tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection | Device | A pre specified amount will be injected in tissue at selected timepoints |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound Analyses | Ultrasound of injection site tissue analyses (dermal thickness (mm), elastosis (mm) and microvascular formation) by PI at various timepoints | 6 months, 3 months and 2 weeks prior to surgery timepoint(s) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Adverse event reporting | through study completion, an average of 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann P Marx, MD | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocean Clinic - Av. Ramon y Cajal 7, 29601 | Marbella | Spain |
individual data will be summarized for analyses
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2026 | Jun 17, 2026 | 3 | ||
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D000075662 | Injection Site Reaction |
| ID | Term |
|---|---|
| D005119 | Extravasation of Diagnostic and Therapeutic Materials |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Injections will be in redundant abdominal tissue scheduled to be removed at end of study
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| D064419 | Chemically-Induced Disorders |