Clinical trials: Microtia
Secondary Ear Reconstructions Based on Nagata Method
Secondary Ear Reconstructions Based on Nagata Method
The goal of this observational study is to provide a feasible surgical strategy based on Nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes.
- Trial name
- NCT05604456
- Testing
- secondary ear reconstruction based on Nagata method
- Where
- China
- Volunteers
- 7 people
- Sponsor
- Xiaohui Su
Rectus Abdominis and External Oblique Muscle Infiltration Analgesia
Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work?
Donor-site pain is an adverse effect of autologous ear reconstruction. A well-planned pain management protocol is needed. The objective of this study was to introduce rectus abdominis and external oblique muscle infiltration…
- Trial name
- NCT06118216
- Testing
- rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia, intravenous patient-controlled anesthesia
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Xiaohui Su
Ear Deformities, Acquired, Ear; Deformity, Congenital
Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures
This study evaluates the efficacy of the AuryzoN devices in the ear and nose reconstruction surgeries, both in terms of operative time and overall quality of reconstruction.
- Conditions
- Ear Deformities, Acquired, Ear; Deformity, Congenital, Microtia, Nose Deformity
- Trial name
- NCT03624608
- Testing
- AuryzoN Family of Devices
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Reconstrata, LLC
Microtia, Congenital, Microtia
Rib Microtia and the Erector Spinae Plane (ESP) Block
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block.
- Conditions
- Microtia, Congenital, Microtia, Anesthesia, Local, Anesthesia
- Trial name
- NCT03729427
- Testing
- Erector Spinae Plane Block
- Where
- United States
- Sponsor
- Stanford University
Microtia, Microtia-Anotia
Craniofacial Microsomia: Accelerating Understanding of the Significance and Etiology
The CAUSE study is a multicenter study, with domestic (n=4) and international (n=6) study sites. Children and young adults (ages 0-18) who have microtia and/or craniofacial microsomia and their parents are invited to participate.
- Conditions
- Microtia, Microtia-Anotia, Craniofacial Microsomia, Goldenhar Syndrome
- Trial name
- CAUSE (NCT04351893)
- Where
- 10 sites in United States, Colombia and 2 more
- Volunteers
- 935 people
- Sponsor
- Seattle Children's Hospital
Microtia
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia (Australia)
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
- Trial name
- AUR-201 (NCT06225336)
- Testing
- AUR-201
- Where
- Australia
- Volunteers
- 2 people
- Sponsor
- Auregen Biotherapeutics, SA
Congenital Microtia
Deep Learning for Flap Perfusion Detection
The aim of this study is to develop a convolutional neural network-based image recognition model to identify flap perfusion abnormalities after first-stage auricular reconstruction in patients with congenital microtia.
- Trial name
- DL-FPA (NCT07846332)
- Testing
- AI-assisted remote monitoring of flap perfusion abnormalities after first-stage auricular reconstruction
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Jing Xu
Deafness Caused by High Grade Microtia or Ear Atresia
OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
The aim of this study is to compare speech perception in noise with one activated Osia (unilateral) versus two activated Osia (bilateral), in children with high grade microtia/ear atresia fitted with bilateral Osia implants.
- Trial name
- APLOSIA (NCT07358728)
- Testing
- Audiological tests, Speech, Spatial and Qualities of Hearing Scale
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Craniofacial Microsomia, Hemifacial Microsomia
Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
This study is a multi-center, longitudinal cohort study of 125 infants with craniofacial microsomia (CFM) and 100 infants without craniofacial anomalies.
- Conditions
- Craniofacial Microsomia, Hemifacial Microsomia, Oculo-Auriculo-Vertebral-Syndrome, Goldenhar Syndrome
- Trial name
- CLOCK (NCT02224677)
- Where
- 5 sites in United States
- Volunteers
- 417 people
- Sponsor
- Seattle Children's Hospital
Congenital Microtia
Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia
Aims and objectives: To evaluate the clinical application and effectiveness of a perioperative position management program constructed using the ADDIE model for patients with congenital microtia.
- Trial name
- NCT06569927
- Testing
- Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.
- Where
- China
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Eye & ENT Hospital of Fudan University
Microtia
AuriNovo for Auricular Reconstruction
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.
- Trial name
- NCT04399239
- Testing
- AuriNovo
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- 3DBio Therapeutics
Microtia
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
- Trial name
- AUR-201 (NCT06072040)
- Testing
- AUR-201
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Auregen Biotherapeutics, SA
Microtia
Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Platelet-rich plasma (PRP) has mixed growth factors such as TGF-ß1 and TGF-ß2, vascular epithelial growth factor (VEGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF).
- Trial name
- NCT00958802
- Testing
- Platelet-rich plasma (PRP), Chondrocyte culture with FBS medium
- Where
- Taiwan
- Volunteers
- 6 people
- Sponsor
- Taipei Medical University WanFang Hospital
Microtia, Microtia, Congenital
Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery
Background: Children with microtia complain of severe postoperative pain during early postoperative days after rib cartilage harvest for auricular reconstruction.
- Trial name
- NCT04192708
- Testing
- intercostal nerve block under direct vision, intercostal nerve block under ultrasound guidance, paravertebral block under ultrasound guidance
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Eye & ENT Hospital of Fudan University
Crohn Disease, Microtia
Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease
In this study, the microbiota sequencing was used to investigate the changes of microbiota in the terminal ileum and the middle part of ascending colon, the mesenteric adipose tissue of ileum and ascending mesocolon, and oral…
- Conditions
- Crohn Disease, Microtia, Ileocecal; Lesion
- Trial name
- NCT05615116
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai 10th People's Hospital
Congenital Microtia
Case Management for Microtia
The aim of this study is to develop an intelligent, full-course case management model for patients with microtia, enabling them to receive continuous, individualized nursing and health management services across the stages from…
- Trial name
- NCT07846345
- Testing
- Microtia case-management platform
- Where
- China
- Volunteers
- 188 people
- Sponsor
- Jing Xu
Microtia, Scar
Silicone Gel to Improve Scar in Microtia Patients
Effort to reduce post-surgical scar is especially important for microtia patients. Even the scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear auricle projection.
- Trial name
- NCT02518035
- Testing
- Silicone Gel
- Where
- Taiwan
- Volunteers
- 32 people
- Sponsor
- Chang Gung Memorial Hospital
Ear Cartilage, Platelets
Use of Platelet-enriched Plasma During Auricular Reconstruction
In this study investigators are trying to determine the benefits of using platelet enriched plasma during the second stage of auricular reconstruction. The intervention will be blinded to the surgeon and the surgical team.
- Conditions
- Ear Cartilage, Platelets, Microtia-Anotia
- Trial name
- NCT03215979
- Testing
- Platelet enriched plasma administration
- Where
- Mexico
- Volunteers
- 36 people
- Sponsor
- Hospital General Dr. Manuel Gea González
Microtia
Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201
Long-term follow-up of unilateral microtia patients implanted with AUR-201.
- Trial name
- AUR-201 (NCT06078566)
- Testing
- AUR-201
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Auregen Biotherapeutics, SA
Microtia
Auricular Reconstruction in Microtia by Medpor Implant Following Tissue Expansion
The study involves patients with microtia of certain criteria will undergo tissue expansion by silicone bags in the postauricular region then Medpor implants will be applied undercover of the expanded skin for reconstruction of…
- Trial name
- NCT05068362
- Testing
- Auricular reconstruction
- Where
- Egypt
- Volunteers
- 3 people
- Sponsor
- Assiut University