Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Train… (NCT07718451) | Clinical Trial Compass
RecruitingNot Applicable
Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy
China110 participantsStarted 2026-05-20
Plain-language summary
This study aims to determine whether multi-patient CT-derived digital twin anatomical variability training can shorten the early clinical learning curve of novice bronchoscopists compared with conventional anatomically uniform bronchoscopy simulation training.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Residents, fellows, or specialty trainees in pulmonary medicine, critical care medicine, thoracic surgery, anesthesiology, or related specialties whose training programs require flexible bronchoscopy training.
. Previously performed ≤5 flexible bronchoscopies as primary operator.
. No prior formal bronchoscopy simulation training course experience.
. Able and willing to provide written informed consent and permit use of training logs, procedural videos, Ontario Bronchoscopy Assessment Tool (OBAT) scores, and clinical learning curve data for research purposes.
. Age ≥18 years.
. Scheduled to undergo elective low-risk or low-to-moderate-risk diagnostic flexible bronchoscopy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
Timeframe: From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
. Clinically suitable for supervised novice-performed airway inspection, bronchoalveolar lavage, simple brushing, or other low-risk sampling procedures considered safe by the supervising bronchoscopist.
. Able to understand and provide written informed consent and willing to complete pre-procedure anxiety and post-procedure experience questionnaires.
Exclusion criteria
. Previously performed \>5 flexible bronchoscopies or previously completed a structured bronchoscopy simulation training program.
. Planned departure from the training program during the study period or anticipated inability to complete follow-up through at least clinical cases 1-30.
. Unable to participate in simulation training or unwilling to permit procedural video recording.
. Significant additional bronchoscopy training exposure outside the study protocol; such cases may not necessarily be excluded but will be documented and addressed in sensitivity analyses.
. Emergency bronchoscopy, intubated intensive care unit patients, severe hypoxemia, or significant hemodynamic instability.
. Therapeutic bronchoscopy, complex central airway stenosis, high bleeding risk, procedures requiring advanced interventional techniques, or cases considered unsuitable for novice participation.
. Complex sampling procedures such as EBUS-TBNA, transbronchial lung biopsy, or cryobiopsy will not be included in the primary endpoint case set and may be analyzed separately as exploratory subgroups or in future studies.
. Refusal of trainee participation or refusal of procedural recording and/or questionnaire completion.