Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03624608
Other study ID # AZN-001
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date March 1, 2027

Study information

Verified date March 2024
Source Reconstrata, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. Research participants will undergo reconstruction either using the AuryzoN device or through current methods (traditional manual processing) at the discretion of their surgeon prior to the start of surgery.


Description:

The AuryzoN devices are a family of two (2) devices that, in conjunction, serve to process substrates of autologous-derived or cadaveric cartilage used in the reconstruction of various structures of the body, namely ear and nose. The devices are to be used in the operating room to cut and carve substrates of tissue into components, which are then assembled into the final ear or nose, that will then be implanted by the plastic surgeon into the appropriate area. This device family serves to replace the current step in this reconstructive procedure, which involves the time-consuming and error-prone process of manual cartilage processing. Participants will be given the option to participate in the study. If the participants so choose, they will undergo ear or nose reconstruction using the AuryzoN devices or traditional manual processing at the discretion of their surgeon prior to the start of surgery. The following outcome measures will be measured: operative time, error rates, objective quality outcomes of reconstruction, subjective quality outcomes of reconstruction, and patient satisfaction.


Recruitment information / eligibility

Status Suspended
Enrollment 100
Est. completion date March 1, 2027
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients aged 1-100 of sufficient health required to undergo ear/nose reconstruction under general anesthesia - Pre-existing physical deformity of the ear, nose, or eyelid necessitating surgical reconstruction - Sufficient autologous or cadaveric rib cartilage for use by the AuryzoN system for cartilage processing Exclusion Criteria: - Patients with ear/nose/eyelid deformities not requiring surgical correction - Patients without sufficient rib cartilage for use by the AuryzoN system and those who do not desire cadaveric cartilage use - Patients in poor health to undergo surgery under general anesthesia - Patients whose desired ear/nose/eyelid exceeds the dimensions/shapes of those pre-fabricated blades used in the AuryzoN system

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AuryzoN Family of Devices
The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).

Locations

Country Name City State
United States Cincinnati Children's Hospital Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
Reconstrata, LLC Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total cartilage processing time Total operative time spent by the surgeon preparing cartilage substrate into finished structures Three years (until 2023)
Primary Objective Quality of Reconstruction An objective scoring system will be developed to score ears and noses based on anatomic accuracy, and reconstructed ears/noses will be scored using this system.
Scoring system scale: The following metrics will be assessed by independent observers on a scale from 0-5, with 5 indicating perfect anatomic fidelity as compared to the patient's contralateral ear (or a model ear if no contralateral ear is available) or model nose and 0 indicating complete anatomical difference or loss of that structure.
The following ear and nose subcomponents will be graded:
Ear: Helix, antihelix, tragus, crus, anatomical proportion of all substrates as compared to each other substrate.
Nose: Septum, alar cartilages, lateral cartilages, horizontal strut, anatomical proportion of all substrates as compared to each other substrate.
Up to 1 year post-op (until 2023)
Secondary Total operative time Total operative time by the surgeon performing the reconstructive surgery Three years (until 2023)
Secondary Cartilage processing error rate Number of errors (defined as anatomic deviations) incurred during cartilaginous processing Three years (until 2023)
Secondary Patient satisfaction Subjective survey completed by patients asking about satisfaction with reconstruction Up to 1 year post-op (until 2023)
Secondary Subjective Quality of Reconstruction Images of completed ear/nose reconstructions with the AuryzoN system will be presented to surgeons and lay-people to determine overall subjective quality of reconstruction Up to 1 year post-op (until 2023)
See also
  Status Clinical Trial Phase
Recruiting NCT05288790 - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT Phase 2
Recruiting NCT05963659 - Nitrate Modulates Cognitive Impairment Via Oral Microbiota. N/A
Completed NCT04130321 - Demonstration of the Prebiotic-like Effects of Camu-camu Consumption Against Obesity-related Disorders in Humans N/A
Recruiting NCT05929976 - InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Withdrawn NCT04230746 - Effect of Antibiotics on Urinary Microbiome Early Phase 1
Active, not recruiting NCT06289283 - Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder
Recruiting NCT05714566 - Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients
Enrolling by invitation NCT06225336 - Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia (Australia) Phase 1
Recruiting NCT05068362 - Auricular Reconstruction in Microtia by Medpor Implant Following Tissue Expansion N/A
Completed NCT02224677 - Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
Not yet recruiting NCT05615116 - Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease
Enrolling by invitation NCT06220994 - the Gut Microbiome and Metabolomics in Chronic Lower extreMities Threatening Ischemia
Completed NCT00958802 - Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies Phase 0
Recruiting NCT06087874 - Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice Phase 2
Not yet recruiting NCT06394687 - The Digestion of Protein Powders in Healthy Participants Using SIMBA and LIMBA Capsule N/A
Completed NCT05417360 - Akkermansia and Weight Maintenance N/A
Recruiting NCT02518035 - Silicone Gel to Improve Scar in Microtia Patients Phase 4
Recruiting NCT06072040 - Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia Phase 1/Phase 2
Recruiting NCT06078566 - Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201 Phase 1/Phase 2
Not yet recruiting NCT03729427 - Rib Microtia and the Erector Spinae Plane (ESP) Block N/A