Treatment of Pectus Excavatum Deformity Using Macrolane Filler
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum|
- PEEQ [ Time Frame: Jul 2016 ] [ Designated as safety issue: No ]To evaluate improvement from baseline in general self-esteem and emotion at 1, 3, 6, 12 and 24 months after treatment with Macrolane VRF20, using a modified version of the pectus excavatum evaluation questionnaire (PEEQ) before and after treatment.
- Subject satisfaction [ Time Frame: Jul 2016 ] [ Designated as safety issue: No ]Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment.
- Duration [ Time Frame: Jul 2016 ] [ Designated as safety issue: No ]Estimate duration of Macrolane VRF20 calculated using MRI images at 12 months (and 24 months for a subset of patients).
- Placement [ Time Frame: Jul 2016 ] [ Designated as safety issue: No ]Assess placement using MRI at 1 and 12 months post treatment.
- Adverse event [ Time Frame: Jul 2016 ] [ Designated as safety issue: Yes ]To study safety throughout the study period, i.e. up to 24 months after treatment, based on evaluation of reported Adverse Events.
- Downtime [ Time Frame: Jul 2016 ] [ Designated as safety issue: Yes ]Evaluate recovery time after treatment using 14-days subject diary.
- Downtime 2 [ Time Frame: Jul 2016 ] [ Designated as safety issue: Yes ]Evaluate days hospitalized or on sick leave after treatment.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Macrolane VRF20
All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity.
Device: Macrolane VRF20
Injection treatment with Macrolane VRF20
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750112
|Principal Investigator:||Per Hedén, MD, PhD||Akademikliniken|
|Principal Investigator:||Raphael Sinna, MD, PhD||University Hospital of Amiens|