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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Injection treatment with Macrolane VRF20
Raphael Sinna
Amiens, France
Per Heden
Stockholm, Sweden
PEEQ
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.
Time frame: Jul 2016
Subject satisfaction
Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment.
Time frame: Jul 2016
Duration
Estimate duration of Macrolane VRF20 calculated using MRI images at 12 months (and 24 months for a subset of patients).
Time frame: Jul 2016
Placement
Assess placement using MRI at 1 and 12 months post treatment.
Time frame: Jul 2016
Adverse event
To study safety throughout the study period, i.e. up to 24 months after treatment, based on evaluation of reported Adverse Events.
Time frame: Jul 2016
Downtime
Evaluate recovery time after treatment using 14-days subject diary.
Time frame: Jul 2016
Downtime 2
Evaluate days hospitalized or on sick leave after treatment.
Time frame: Jul 2016
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