Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-02-28 @ 7:09 PM
Study NCT ID:
NCT01750112
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Pectus Excavatum Deformity Using Macrolane Filler
Sponsor:
Galderma R&D
Organization:
Study Overview
Official Title:
An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: