None listed
Conditions
Interventions
Medical Device : Ear reconstruction with patient specific implant (TnR BellaPore-E)
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria for selecting research subjects 1) Adults between 19 and 65 years of age 2) A person who does not have clinically significant abnormalities in a laboratory examination prior to surgery 3) Patients with external microtia who require surgical treatment under the judgment of the tester 4) A person who has a defect in part of the ear due to congenital malformation such as microtia; 5) Type II, III according to the classification of Tanzer's ears. 6) A person with a general anesthetic condition 7) A person who has been confirmed negatively in the pregnancy test and agrees to be contraceptive during the clinical trial period 8) A person who voluntarily agrees to the clinical trial and is willing and able to comply with the test plan.
Exclusion criteria
Exclusion criteria: Criteria for excluding research subjects 1) Pregnant or breastfeeding 2) Patients with untreated ear trauma at the time of screening 3) Patients who are contaminated with open trauma, etc. at the time of screening 4) Patients with unhealed inflammation, granulomatosis, and infection at the time of screening 5) Patients with acute inflammation and carcinoma in the surgical field at the time of screening 6) Patients with bilaterality microtia at the time of screening 7) Patients with immune diseases including acquired immunodeficiency at the time of screening 8) Patients who received local hormone therapy within three months at the time of screening 9) Patients who have hematological diseases or tend to bleed at the time of screening; 10) Patients who have or are scheduled to have a history of therapeutic radiation irradiation of the craniocervical, including the operating department, at the time of screening; 11) Patients who need to use steroids for a long period of time at the time of screening 12) A person who is allergic to polycaprolactone, a component of medical devices used in this clinical trial 13) Those who participated in other clinical trials at the time of screening and within the previous three months 14) Other researchers determined that the clinical trial was inappropriate 15) A person who takes a blood coagulant, steroids, immunosuppressant, etc. that may affect clinical outcomes; 16) A person whose pregnancy test results are positive (Only those who are confirmed to be negative may participate in the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of ear restoration by independent assessors at 48 weeks ± 2 weeks after surgery compared to the normal volume of the ear before surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Evaluation of ear restoration rate (%) by independent assessors at (0 weeks) + 2 weeks immediately after surgery compared to normal ear volume before surgery.(2) Evaluation of the ear retention rate (%) by an independent evaluator at 48 weeks ± 2 weeks after surgery compared to the volume of the ear immediately after surgery (0 weeks) + 2 weeks after surgery.(3) Evaluation of satisfaction with appearance by independent evaluators for microtia restoration after 48 weeks ± 2 weeks of surgery using 7-scale.(4) Evaluating the satisfaction level of microtia restoration after 48 weeks ± 2 weeks of surgery using ANA scale | — |
Countries
Korea, Republic of
Contacts
Public ContactMin Ji Kim
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed