AuriNovo for Auricular Reconstruction (NCT04399239) | Clinical Trial Compass
TerminatedPhase 1/2
AuriNovo for Auricular Reconstruction
Stopped: Company decision, not safety related.
United States2 participantsStarted 2021-08-09
Plain-language summary
AuriNovo provides a patient-specific, biological construct for use in the surgical reconstruction of the external ear in people born with microtia Grades II-IV. This Phase 1 / 2A study is being conducted to collect preliminary safety data on microtic ear reconstruction using AuriNovo, fine-tune technical, logistical, surgical, and post-surgical care aspects related to implantation, and to gather preliminary efficacy data including short- and longer-term in vivo duration and biological status of the implant.
Who can participate
Age range6 Years ā 25 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Pediatric children 6-11, adolescents 12-16, or adults 17-25 years old
ā. Born with unilateral microtia Grade II, III, or IV
ā. No previous surgical procedure for auricular reconstruction
ā. Have undergone an audiological assessment prior to enrollment and surgeon confirmation that study participation will not preclude future hearing correction options
ā. Normal or near normal hairline position
ā. Able to adhere to the follow-up schedule and post-surgery care instructions
ā. Ability for the subject and/or guardian to understand and give informed consent
ā. Healthy subjects with no history of cancer, problematic wound healing, or immune disorders
Exclusion criteria
ā. Previous cochlear implant surgery
ā
What they're measuring
1
Safety through assessment of AEs
Timeframe: 3 months
2
Efficacy as measured through overall satisfaction scores
Timeframe: 3 months
3
Efficacy as measured through overall satisfaction scores
. 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.
ā. Sensitivity to broad-spectrum aminoglycoside antibiotics containing any of the following: streptomycin, gentamycin tobramycin, amikacin, kanamycin, neomycin, or plazomicin.
ā. 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.
ā. Patients previously diagnosed/evaluated for any of the following syndromes: