NCT05273060

Brief Summary

The purpose of this study is to gather information on the safety and effectiveness and compare nasal reconstruction standard planning versus 3D preoperative scanning/printing/planning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 18, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2024

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

2.6 years

First QC Date

January 9, 2022

Last Update Submit

June 28, 2025

Conditions

Nasal Surgical ProceduresRegenerative Medicine

Outcome Measures

Primary Outcomes (1)

  • Viable nasal reconstruction

    Total number of subjects to have successful nasal reconstruction with transfer of viable tissue to reconstruct nasal defect

    6 months

Secondary Outcomes (1)

  • Nasal breathing

    6 months

Study Arms (2)

Standard of Care Nasal Reconstruction Planning

NO INTERVENTION

Subjects undergoing nasal reconstruction will have standard planning for procedure.

3D Nasal Reconstruction Planning

EXPERIMENTAL

Subjects undergoing nasal reconstruction will have 3D planning utilized by the surgical team for the procedure.

Procedure: 3D Nasal Reconstruction Planning

Interventions

3D Nasal Reconstruction PlanningPROCEDURE

3D molds or models to use in the reconstruction of nasal cartilage

3D Nasal Reconstruction Planning

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or female, age range is ≥ 18 to ≤ 100, based on historical surgical experience.
  • Patients undergoing nasal reconstruction.
  • Patients will be identified from the Facial Plastic Surgery clinic of the PI.

You may not qualify if:

  • \- Patients \< 18 are excluded because these cases are in combination with providers from PCH and patients have shared/limited postoperative follow up as a result.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Study Officials

  • Brittany Howard, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2022

First Posted

March 10, 2022

Study Start

May 18, 2022

Primary Completion

December 19, 2024

Study Completion

December 19, 2024

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)