Treatment of Pectus Excavatum Deformity Using Macrolane Filler

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01750112
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : May 9, 2017
Pharma Consulting Group AB
Information provided by (Responsible Party):
Q-Med AB

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.

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)
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
Study Start Date : December 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Macrolane VRF20
All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity.
Device: Macrolane VRF20
Injection treatment with Macrolane VRF20

Primary Outcome Measures :
  1. 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.

  2. Subject satisfaction [ Time Frame: Jul 2016 ]
    Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment.

  3. 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).

  4. Placement [ Time Frame: Jul 2016 ]
    Assess placement using MRI at 1 and 12 months post treatment.

  5. 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.

  6. Downtime [ Time Frame: Jul 2016 ]
    Evaluate recovery time after treatment using 14-days subject diary.

  7. Downtime 2 [ Time Frame: Jul 2016 ]
    Evaluate days hospitalized or on sick leave after treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Give verbal and written informed consent to participate in the study.
  2. Be a healthy male of 18 years or more.
  3. Have a pectus excavatum deformity without functional problems; score 4 in items 10, 11 and 12 of the PEEQ, indicating there is no functional impairment due to the pectus excavatum deformation.
  4. Present normal cardiac function as assessed by ECG and echocardiogram.
  5. Present normal pulmonary function as assessed by pulmonary function test.
  6. Present a chest X-ray taken within 12 months prior to the baseline visit, without clinically significant defects to heart, lungs, skeleton, ribs, sternum or spinal cord except for the pectus excavatum defect, in the opinion of the Investigator.
  7. Have the ability to understand and comply with the requirements of the study.

Exclusion Criteria:

  1. Score 1, 2 or 3 in either of items 10, 11 and 12 of the PEEQ, indicative of functional problems due to the pectus excavatum deformity.
  2. Previous treatment for the same indication.
  3. Known or suspected hypersensitivity to hyaluronic acid based products.
  4. BMI < 20.
  5. A history of severe allergies manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies (as judged by the Investigator).
  6. Known allergy to any anesthesia planned during the study.
  7. Presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the study.
  8. Subjects with bleeding disorders or subjects who are taking thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, including non-steroidal anti-inflammatory agents and acetylsalicylic acid, two weeks before treatment.
  9. Subjects on immunomodulatory therapy (suppressive or stimulatory).
  10. Subjects with contraindications for MRI, such as presence of pacemaker, clips or splinter, or tendency for claustrophobia.
  11. Any condition which in the opinion of the Investigator makes the subject unsuitable for inclusion (e.g., subjects not likely to participate for the duration of the study).
  12. Use of any investigational drugs or devices within 30 days prior to baseline.
  13. Subjects who are study site staff for this study, or close relatives of the study site staff, as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01750112

Raphael Sinna
Amiens, France
Per Heden
Stockholm, Sweden
Sponsors and Collaborators
Q-Med AB
Pharma Consulting Group AB
Principal Investigator: Per Hedén, MD, PhD Akademikliniken
Principal Investigator: Raphael Sinna, MD, PhD University Hospital of Amiens

Responsible Party: Q-Med AB Identifier: NCT01750112     History of Changes
Other Study ID Numbers: 31GC1201
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Q-Med AB:
Pectus excavatum
funnel chest
sunken chest

Additional relevant MeSH terms:
Congenital Abnormalities
Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities