Trials / Completed
CompletedNCT06093815
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
Prospective, Single Site, Controlled Comparative Study to Identify and Assess Tissue Responses After Injection With Various Biostimulatory Products
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Merz North America, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Injection | A pre specified amount will be injected in tissue at selected timepoints |
Timeline
- Start date
- 2023-09-08
- Primary completion
- 2024-05-01
- Completion
- 2024-11-01
- First posted
- 2023-10-23
- Last updated
- 2024-12-13
Locations
1 site across 1 country: Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06093815. Inclusion in this directory is not an endorsement.