Treatment of Pectus Excavatum Deformity Using Macrolane Filler
|ClinicalTrials.gov Identifier: NCT01750112|
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : May 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pectus Excavatum Deformity||Device: Macrolane VRF20||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Macrolane VRF20
All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity.
Device: Macrolane VRF20
Injection treatment with Macrolane VRF20
- PEEQ [ Time Frame: Jul 2016 ]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 ]Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment.
- Duration [ Time Frame: Jul 2016 ]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 ]Assess placement using MRI at 1 and 12 months post treatment.
- Adverse event [ Time Frame: Jul 2016 ]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 ]Evaluate recovery time after treatment using 14-days subject diary.
- Downtime 2 [ Time Frame: Jul 2016 ]Evaluate days hospitalized or on sick leave after treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750112
|Principal Investigator:||Per Hedén, MD, PhD||Akademikliniken|
|Principal Investigator:||Raphael Sinna, MD, PhD||University Hospital of Amiens|