3DBio12A2020, AuriNovo

What is the Purpose of this Study?

-Collect preliminary safety data -Address unanticipated technical, logistical, surgical, and post-surgical care aspects related to implantation of the Investigational Product (IP) -Gather preliminary efficacy data including short- and longer-term in vivo duration -Histological analysis of the IP implanted ~3-6 months in vivo

Eligibility

1. Pediatric children 6-11, adolescents 12-16, or adults 17-25 years old
2. Born with unilateral microtia Grade II, III, or IV
3. No previous surgical procedure for auricular reconstruction
4. Have undergone an audiological assessment prior to enrollment and surgeon confirmation that study participation will not preclude future hearing correction options

Inclusion Criteria:

1. Pediatric children 6-11, adolescents 12-16, or adults 17-25 years old
2. Born with unilateral microtia Grade II, III, or IV
3. No previous surgical procedure for auricular reconstruction
4. Have undergone an audiological assessment prior to enrollment and surgeon confirmation that study participation will not preclude future hearing correction options
5. Normal or near normal hairline position
6. Able to adhere to the follow-up schedule and post-surgery care instructions
7. Ability for the subject and/or guardian to understand and give informed consent
8. Healthy subjects with no history of cancer, problematic wound healing, or immune disorders

Exclusion Criteria:

1. Previous cochlear implant surgery
2. Patients with prior surgery in the temporal, parietal, or mastoid regions of the affected side that resulted in scarring that may affect the outcome of microtia reconstruction surgery.
3. Sensitivity to broad-spectrum aminoglycoside antibiotics containing any of the following: streptomycin, gentamycin tobramycin, amikacin, kanamycin, neomycin, or plazomicin.
4. Sensitivity to materials of porcine origin including pork products. For subjects with no known exposure to porcine materials including pork products, sensitivity as confirmed at baseline through a positive porcine skin sensitivity test.
5. Patients previously diagnosed/evaluated for any of the following syndromes:
1. CHARGE (Coloboma, Heart defect, choanal Atresia, Retarded growth and development, Genital hypoplasia, Ear anomalies) syndrome,
2. Branchio-oto-renal (BOR) syndrome
3. Patients with renal dysfunction of any etiology
6. Patients with abnormal renal function determined at baseline with a blood test.
7. Patients with a history of keloid formation.
8. Patients with current skin infection.
9. Patients on immunosuppressants.
10. Any cognitive disorders where the patient would not be able to complete subject assessment questionnaires.
11. Lifestyle activities likely to affect healing or ability to adhere to the protocol (e.g., active contact sports and protective gear interferes with wearing post-operative ear protection)
12. Patients requiring chronic use of any headgear (e.g., CPAP) that would interfere with the ability to wear post-operative ear protection.
13. Pregnant females (a negative pregnancy test is required for females with reproductive potential)
14. Female patients who are nursing/lactating
15. Patients of reproductive potential (male and female) unwilling to use effective contraception during the first post-operative year.
For this first-in-human study, microtia patients with significant craniofacial asymmetries or deformities from other syndromes will be excluded in order to aid initial assessments of efficacy of AuriNovo. The following syndromes or conditions are additional exclusion factors:
16. Treacher-Collins Syndrome
17. Nager Syndrome
18. Goldenhar syndrome or hemifacial microsomia plus an occlusal cant of 20 degrees or greater
19. Absence of vertical ramus (as diagnosed on physical exam or CT)
20. Absence of zygoma (as diagnosed on physical exam or CT)
21. Significant orbital asymmetry or micro-ophthalmia (as diagnosed on physical exam or CT)

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Multicenter, Single Arm, Prospective, Open-Label, Staged Study of the Safety and Efficacy of the AuriNovo Construct for Auricular Reconstruction in Subjects with Unilateral Microtia

Study Details

Disease Type/Condition

Facial surgery, Microtia

Principal Investigator

Reinisch, John

Age Group

Both

Phase

I/II

IRB Number

STUDY00000888

ClinicalTrials.gov ID

NCT04399239

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org