Clinical Trial: Treatment of Pectus Excavatum Deformity Using Macrolane Filler

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum

Brief Summary:

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.

Detailed Summary:
Sponsor: Q-Med AB

Current Primary Outcome:

• 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.

Original Primary Outcome:

• PEEQ [ Time Frame: Dec 2015 ]
  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 ]
  Evaluate subject satisfaction at each visit after treatment.
• Duration [ Time Frame: Dec 2015 ]
  Estimate duration of Macrolane VRF20 calculated using MRI images.
• Placement [ Time Frame: Dec 2015 ]
  Assess placement using MRI at 1 and 12 months post treatment.
• Adverse event [ Time Frame: Dec 2015 ]
  To study safety throughout the study period based on evaluation of reported Adverse Events.
• Downtime [ Time Frame: Dec 2015 ]
  Evaluate recovery time after treatment using subject diary.
• Downtime 2 [ Time Frame: Dec 2015 ]
  Evaluate days hospitalized or on sick leave after treatment.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Q-Med AB

Dates:
Date Received: December 12, 2012
Date Started: December 2012
Date Completion:
Last Updated: May 8, 2017
Last Verified: May 2017