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:||Allocation: Non-Randomized
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: Dec 2015 ] [ Designated as safety issue: No ]To evaluate improvement from baseline in general self-esteem and emotion at each follow up visit after treatment with Macrolane VRF20, using a modified version of the pectus excavatum evaluation questionnaire (PEEQ) before and after treatment.
- Subject satisfaction [ Time Frame: Dec 2015 ] [ Designated as safety issue: No ]Evaluate subject satisfaction at each visit after treatment.
- Duration [ Time Frame: Dec 2015 ] [ Designated as safety issue: No ]Estimate duration of Macrolane VRF20 calculated using MRI images.
- Placement [ Time Frame: Dec 2015 ] [ Designated as safety issue: No ]Assess placement using MRI at 1 and 12 months post treatment.
- Adverse event [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]To study safety throughout the study period based on evaluation of reported Adverse Events.
- Downtime [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]Evaluate recovery time after treatment using subject diary.
- Downtime 2 [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]Evaluate days hospitalized or on sick leave after treatment.
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity.
|Device: Injection treatment with Macrolane VRF20|
|Raphael Sinna||Not yet recruiting|
|Contact: Raphael Sinna, Md, PhD firstname.lastname@example.org|
|Principal Investigator: Raphael Sinna, MD, PhD|
|Sub-Investigator: Pascal Berna, MD|
|Markus Klöppel||Not yet recruiting|
|Contact: Mrkus Klöppel, MD email@example.com|
|Principal Investigator: Markus Klöppel, MD|
|Contact: Per Heden, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Per Heden, MD, PhD|
|Sub-Investigator: Per Bergenz, MD|
|Principal Investigator:||Per Hedén, MD, PhD||Akademikliniken|
|Principal Investigator:||Raphael Sinna, MD, PhD||University Hospital of Amiens|
|Principal Investigator:||Markus Klöppel, MD||MediCenter München-Solln|