NCT07580573

Brief Summary

This study aims to thoroughly assess the predictive accuracy of artificial intelligence-based nasal outcome simulations by comparing AI-generated preoperative predictions with objective postoperative nasal morphology using digital image analysis. To assess accuracy of AI-image measurement compared with imageJ software

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jun 2026

Status
not yet recruiting

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

April 21, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

April 21, 2026

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Agreement between ImageJ and AI application measurements

    basline

  • Evaluate the accuracy of AI-based simulation in predicting postoperative aesthetic outcomes following structural rhinoplasty by comparing AI-generated preoperative simulations with actual postoperative nasal morphology using objective digital image a

    basline

Study Arms (1)

AI-Based Assessment

OTHER
Other: AI

Interventions

AIOTHER

using AI-driven simulations which enable the generation of realistic preoperative predictions, thereby improving surgical planning and patient communication.

AI-Based Assessment

Eligibility Criteria

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

You may qualify if:

  • Patients age\> 18 years old.
  • patients schedule for rhinoplasty surgery

You may not qualify if:

  • Pervious nasal trauma that affect anatomical land mark
  • pervious nasal surgery (rhinoplasty or others)
  • patients with psychological disorders.
  • patients with any coagulopathy disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Omer G, Girolamo S, Hamatofiq B, Tofiq S, Mohammed MA, Abdulkarim D, Mohammed S, Gubari M, Habibullah I, Mustafa A, Fatah M, Ahmed S, Kakamad F. Functional, Cosmetic, and Psychological Outcomes after Rhinoplasty. Plast Reconstr Surg Glob Open. 2024 Aug 16;12(8):e6057. doi: 10.1097/GOX.0000000000006057. eCollection 2024 Aug.

    PMID: 39157708BACKGROUND
  • Zhao R, Chen K, Tang Y. Effects of Functional Rhinoplasty on Nasal Obstruction: A Meta-Analysis. Aesthetic Plast Surg. 2022 Apr;46(2):873-885. doi: 10.1007/s00266-021-02741-2. Epub 2022 Jan 31.

    PMID: 35099579BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docter

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 12, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 12, 2026

Record last verified: 2026-05