NCT07466810Not yet recruiting
Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology
Prospective Clinical Study in Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology Based on UE5 Engine
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site. Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality \[MR\] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group. The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 7 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Diseases
- Childhood cancers
- NCT number
- NCT07466810
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Apr 2026 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects did not receive surgical treatment;
- No observation data after randomization. Withdrawal Criteria Withdrawal of subjects from the trial refers to cases where enrolled subjects are determined by the investigator to withdraw from the trial due to conditions that make it inappropriate to continue the trial. In accordance with the informed consent form, subjects have the right to withdraw from the trial midway. Subjects who do not explicitly propose to withdraw but stop receiving treatment and tests and are lost to follow-up are also considered "withdrawn" (or "lost to follow-up"). The reason for withdrawal should be understood and recorded as much as possible, such as: poor subjective curative effect; inability to tolerate certain adverse reactions; inability to continue participating in the clinical study due to personal reasons; economic factors; or lost to follow-up without stating the reason.
- (1) Aggravation or deterioration of the condition during the trial that requires emergency measures; (2) Occurrence of certain comorbidities, complications or special physiological changes in subjects during the trial, making it inappropriate to continue participating in the trial; (3) Voluntary withdrawal by the subject.
- Data Handling of Withdrawn Subjects
- Regardless of the reason, the complete clinical data of subjects who withdraw from the trial shall be retained. For all withdrawn subjects, the trial conclusion form and the reason for withdrawal shall be filled in the case report form (CRF). Generally, there are 6 types of reasons: occurrence of adverse events (including adverse drug reactions and allergic reactions), lack of efficacy (deterioration of condition or occurrence of complications), violation of the trial protocol (including poor compliance), lost to follow-up (including voluntary withdrawal by the patient), termination by the sponsor, or others.
Other illness
- \- Poor general condition, evaluated as unable to tolerate surgical treatment.
- Subjects who have been enrolled in this trial will be excluded if they meet any of the following conditions:
Other
- -Exclusion Criteria (After Enrollment)
- Violation of important inclusion criteria;
Who the study is looking for
- Definite pathological diagnosis of oral cancer before surgery;
- Defects suitable for free flap reconstruction;
- Patients have signed the informed consent form and are willing to cooperate with postoperative follow-up.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.