Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pharma Consulting Group AB | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macrolane VRF20 | Experimental | All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macrolane VRF20 | Device | Injection treatment with Macrolane VRF20 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Jul 2016 |
| Subject satisfaction | Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment. | Jul 2016 |
| Duration | Estimate duration of Macrolane VRF20 calculated using MRI images at 12 months (and 24 months for a subset of patients). | Jul 2016 |
| Placement | Assess placement using MRI at 1 and 12 months post treatment. | 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. | Jul 2016 |
| Downtime | Evaluate recovery time after treatment using 14-days subject diary. | Jul 2016 |
| Downtime 2 | Evaluate days hospitalized or on sick leave after treatment. | Jul 2016 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Per Hedén, MD, PhD | Akademikliniken | Principal Investigator |
| Raphael Sinna, MD, PhD | University Hospital of Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raphael Sinna | Amiens | France | ||||
| Per Heden |
| ID | Term |
|---|---|
| D005660 | Funnel Chest |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stockholm |
| Sweden |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |