Phase
Condition
Pulmonary Nodules
Treatment
Bronchoscopic navigation robot
Conventional electromagnetic navigation bronchoscope
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18-80 years, regardless of gender;
Peripheral pulmonary nodules, planned for single lesion non-anatomical sublobarresection via thoracoscopic assistance after preoperative discussion;
Preoperative assessment indicates that the pulmonary nodules cannot be localizedthrough visual inspection or palpation;
Patients are able to understand the purpose of the trial, have good compliance withexaminations and follow-ups, and voluntarily participate in the clinical trial bysigning an informed consent form.
Exclusion
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: fulfillingone 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; recentmyocardial infarction or unstable angina; severe hypertension and arrhythmias;uncorrectable bleeding tendencies (such as severe coagulopathy, uremia, and severepulmonary hypertension, etc.); severe superior vena cava syndrome; suspected aorticaneurysm; 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 ofmultiple severe allergies or hereditary allergies;
Participation in drug clinical trials in the past 3 months, or currentlyparticipating, or participation in other medical device clinical trials within thepast 30 days;
Other conditions deemed unsuitable for participation in this clinical trial by theinvestigator.
Study Design
Connect with a study center
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai 200025
ChinaActive - Recruiting

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