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AI could speed up complex reconstructive surgery planning

NCT ID NCT06634472

Knowledge-focused Sponsor: The University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an artificial intelligence tool that automatically finds and maps skin blood vessels (perforators) from CT scans. These vessels are critical for a type of reconstructive surgery called fibula free flap, where bone and skin are moved to repair defects. The AI aims to replace the current manual method, which can take hours. The trial will enroll 49 adults needing this surgery and compare the AI's predictions to what surgeons actually find during the operation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
artificial intelligence-enabled skin perforator segmentation tool
What this could lead to
If successful, this AI tool could make reconstructive surgeries faster and more precise by automatically mapping important blood vessels, reducing planning time for surgeons.
What could go wrong
This is a small, early-stage study with only 49 participants. The AI may not be accurate in all patients, and it is not yet proven to improve surgical outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 49 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include patients with maxillary or mandibular neoplastic, inflammatory, and congenital diseases, who require immediate or secondary reconstructive surgery with osteocutaneous fibula free flap.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years, both genders; 2. Provided signed and dated informed consent form; 3. Indicated for immediate or secondary reconstructive surgery with osteocutaneous fibula free flap. Exclusion Criteria: 1. Patients who are pregnant; 2. Patients who have medically compromised conditions and cannot tolerate surgery; 3. Patients who are unable to receive pre-operative computed tomography angiogram scans, such as those with iodine allergy; 4. Patients who have anatomical variation preventing the safe harvest of fibula free flap.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibula flap Microvascular free flap transfer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Hong Kong

    RECRUITING

    Hong Kong, 999077, Hong Kong

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