Trials / Completed
CompletedNCT01750112
Treatment of Pectus Excavatum Deformity Using Macrolane Filler
An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, open, non-comparative and baseline-controlled study to evaluate efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum deformity. Each subject participating in the study will be treated with approximately 50-150 ml of Macrolane VRF20. The amount of study product used will be individually determined in order to achieve an optimal correction of the deformity in each subject.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Macrolane VRF20 | Injection treatment with Macrolane VRF20 |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2016-08-01
- Completion
- 2016-09-01
- First posted
- 2012-12-17
- Last updated
- 2022-08-25
Locations
2 sites across 2 countries: France, Sweden
Source: ClinicalTrials.gov record NCT01750112. Inclusion in this directory is not an endorsement.