| Eligibility |
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.
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