Treatment of Pectus Excavatum Deformity Using Macrolane Filler

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Q-Med AB
Sponsor:
Collaborator:
Pharma Consulting Group AB
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01750112
First received: December 12, 2012
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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 Intervention
Pectus Excavatum Deformity
Device: Injection treatment with Macrolane VRF20

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • PEEQ [ Time Frame: Dec 2015 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate subject satisfaction at each visit after treatment.

  • Duration [ Time Frame: Dec 2015 ] [ Designated as safety issue: No ]
    Estimate duration of Macrolane VRF20 calculated using MRI images.

  • Placement [ Time Frame: Dec 2015 ] [ Designated as safety issue: No ]
    Assess placement using MRI at 1 and 12 months post treatment.

  • Adverse event [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]
    To study safety throughout the study period based on evaluation of reported Adverse Events.

  • Downtime [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]
    Evaluate recovery time after treatment using subject diary.

  • Downtime 2 [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]
    Evaluate days hospitalized or on sick leave after treatment.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Macrolane VRF20
All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity.
Device: Injection treatment with Macrolane VRF20

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750112

Locations
France
Raphael Sinna Not yet recruiting
Amiens, France
Contact: Raphael Sinna, Md, PhD       raphaelsinna@gmail.com   
Principal Investigator: Raphael Sinna, MD, PhD         
Sub-Investigator: Pascal Berna, MD         
Germany
Markus Klöppel Not yet recruiting
Munchen, Germany
Contact: Mrkus Klöppel, MD       mk@drkloeppel.com   
Principal Investigator: Markus Klöppel, MD         
Sweden
Per Heden Recruiting
Stockholm, Sweden
Contact: Per Heden, MD, PhD       per.heden@ak.se   
Principal Investigator: Per Heden, MD, PhD         
Sub-Investigator: Per Bergenz, MD         
Sponsors and Collaborators
Q-Med AB
Pharma Consulting Group AB
Investigators
Principal Investigator: Per Hedén, MD, PhD Akademikliniken
Principal Investigator: Raphael Sinna, MD, PhD University Hospital of Amiens
Principal Investigator: Markus Klöppel, MD MediCenter München-Solln
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01750112     History of Changes
Other Study ID Numbers: 31GC1201
Study First Received: December 12, 2012
Last Updated: November 8, 2013
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Ethics Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 28, 2014