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Clinical Applications of Shape-Sensing Robotic-Assisted Bronchoscopy

Clinical Applications of Shape-Sensing Robotic-Assisted Bronchoscopy in the Diagnosis and Management of Pulmonary Lesions: A prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011312
Enrollment
1500
Registered
2025-12-11
Start date
2025-09-17
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Presence of a pulmonary lesion identified on chest computed tomography (CT), requiring diagnostic biopsy or interventional localization 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, or an equivalent functional status permitting sedation or general anesthesia for the procedure

Exclusion criteria

Exclusion criteria: 1. Any absolute contraindications to bronchoscopy, including: Severe hypoxemia (oxygen saturation < 90%), Severe pulmonary hypertension, Recent myocardial infarction within the past 6 weeks, Unstable angina, Malignant arrhythmias 2. Uncontrolled or irreversible coagulopathy (e.g., platelet count < 50,000/µL) 3. Inability to undergo sedation or general anesthesia due to severe cardiopulmonary dysfunction (e.g., contraindication to general anesthesia) 4. Cervical spine instability 5. Pregnant or breastfeeding women 6. Life expectancy less than 6 months as determined by the attending physician 7. Concurrent participation in another interventional clinical trial that may interfere with the study procedures or outcomes

Design outcomes

Primary

MeasureTime frame
Diagnostic performance of ss-RAB;Localization Performance of ss-RAB

Secondary

MeasureTime frame
Subgroup, Predictive Factor, and Treat Impact Analyses of Diagnostic RAB;Subgroup, Predictive Factor, and Clinical Utility Analyses of Localization RAB

Countries

Korea, Republic of

Contacts

Public ContactHye ran Gwon

National Cancer Center

gwon5500@ncc.re.kr+82-31-920-0541

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026