Treatment of Pectus Excavatum Deformity Using Macrolane Filler
This study is currently recruiting participants.
Verified December 2012 by Q-Med AB
Sponsor:
Q-Med AB
Collaborator:
Pharma Consulting Group AB
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01750112
First received: December 12, 2012
Last updated: December 13, 2012
Last verified: December 2012
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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:
- Give verbal and written informed consent to participate in the study.
- Be a healthy male of 18 years or more.
- 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.
- Present normal cardiac function as assessed by ECG and echocardiogram.
- Present normal pulmonary function as assessed by pulmonary function test.
- 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.
- Have the ability to understand and comply with the requirements of the study.
Exclusion Criteria:
- 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.
- Previous treatment for the same indication.
- Known or suspected hypersensitivity to hyaluronic acid based products.
- BMI < 20.
- 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).
- Known allergy to any anesthesia planned during the study.
- Presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the study.
- 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.
- Subjects on immunomodulatory therapy (suppressive or stimulatory).
- Subjects with contraindications for MRI, such as presence of pacemaker, clips or splinter, or tendency for claustrophobia.
- 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).
- Use of any investigational drugs or devices within 30 days prior to baseline.
- 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
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: | December 13, 2012 |
| 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 June 17, 2013