Treatment of Pectus Excavatum Deformity Using Macrolane Filler

This study is ongoing, but not recruiting participants.
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: April 25, 2016
Last verified: April 2016
  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: Macrolane VRF20

Study Type: Interventional
Study Design: 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: Jul 2016 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment.

  • Duration [ Time Frame: Jul 2016 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assess placement using MRI at 1 and 12 months post treatment.

  • Adverse event [ Time Frame: Jul 2016 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Evaluate recovery time after treatment using 14-days subject diary.

  • Downtime 2 [ Time Frame: Jul 2016 ] [ Designated as safety issue: Yes ]
    Evaluate days hospitalized or on sick leave after treatment.


Enrollment: 23
Study Start Date: December 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macrolane VRF20
All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity.
Device: Macrolane VRF20
Injection treatment with Macrolane VRF20

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Amiens, France
Sweden
Per Heden
Stockholm, Sweden
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
  More Information

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: April 25, 2016
Health Authority: Sweden: Regional Ethical Review Board
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Ethics Committee

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 July 24, 2016