Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT06821451
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-80 years, regardless of gender;
* Peripheral pulmonary nodules, planned for single lesion non-anatomical sublobar resection via thoracoscopic assistance after preoperative discussion;
* Preoperative assessment indicates that the pulmonary nodules cannot be localized through visual inspection or palpation;
* Patients are able to understand the purpose of the trial, have good compliance with examinations and follow-ups, and voluntarily participate in the clinical trial by signing an informed consent form.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from this study:
\- Surgical contraindications that do not meet surgical tolerance standards: fulfilling one major criterion and/or two or more minor criteria.
Major criterion: Forced expiratory volume in 1 second (FEV1) or carbon monoxide diffusion capacity (DLCO) ≤ 50%.
Minor criterion: (1) FEV1 or DLCO 51%-60%; (2) Age ≥ 75 years; (3) Pulmonary hypertension \> 40 mmHg (1 mmHg = 0.133 kPa); (4) Left ventricular ejection fraction (LVEF) ≤ 40%; (5) Arterial blood partial pressure of oxygen (PaO2) \< 55 mmHg or arterial blood oxygen saturation (SpO2) ≤ 88% with arterial blood partial pressure of carbon dioxide (PaCO2) \> 45 mmHg.
* Contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe hypertension and arrhythmias; uncorrectable bleeding tendencies (such as severe coagulopathy, uremia, and severe pulmonary hypertension, etc.); severe superior vena cava syndrome; suspected aortic aneurysm; multiple pulmonary bullae; extremely poor overall condition;
* Female patients who are breastfeeding, pregnant, or trying to conceive;
* Patients with electromagnetic active implantable devices;
* Participants allergic to indocyanine green or anesthetics; or with a history of multiple severe allergies or hereditary allergies;
* Participation in drug clinical trials in the past 3 months, or currently participating, or participation in other medical device clinical trials within the past 30 days;
* Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06821451
Study Brief:
Protocol Section:
NCT06821451