Retrospective Analysis of Influencing Factors, Learning Curve, and Diagnostic Efficiency of Shape-Sensing Robot-Assisted Bronchoscopy for Peripheral Pulmonary Lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039920

Enrollment

Registered

2026-05-06

Start date

2026-05-06

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

D38.1

Interventions

Group 1: A retrospective analysis of all consecutive patients who underwent robot-assisted bronchoscopy using the ION™ Endoluminal System (Intuitive Surgical) at our facility between August 2024 and M

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All consecutive patients who underwent robot-assisted bronchoscopy at our center.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
As this is a retrospective data analysis, no prospective endpoint assessment will be performed. The aim of the study is the retrospective evaluation of navigation accuracy and diagnostic efficiency of shape-sensing robotic-assisted bronchoscopy for peripheral pulmonary lesions. The following primary endpoints will be analyzed: Target Deviation: Distance between the planned target point of the lesion and the actually reached instrument tip, measured in millimeters. Assessment will be performed retrospectively at the time of each bronchoscopy using navigation and imaging data documented during routine clinical care. Diagnostic yield per lesion: Presence of a diagnostic pathological finding of the target lesion. Assessment will be performed retrospectively after completion of the clinical diagnostic workup based on available pathological reports and clinical documentation. No additional data will be collected for the study. All parameters will be obtained exclusively from existing clinical, radiological, procedural, and pathological routine care data.	—

Measure

Time frame

As this is a retrospective data analysis, no prospective endpoint assessment will be performed. The aim of the study is the retrospective evaluation of navigation accuracy and diagnostic efficiency of shape-sensing robotic-assisted bronchoscopy for peripheral pulmonary lesions. The following primary endpoints will be analyzed: Target Deviation: Distance between the planned target point of the lesion and the actually reached instrument tip, measured in millimeters. Assessment will be performed retrospectively at the time of each bronchoscopy using navigation and imaging data documented during routine clinical care. Diagnostic yield per lesion: Presence of a diagnostic pathological finding of the target lesion. Assessment will be performed retrospectively after completion of the clinical diagnostic workup based on available pathological reports and clinical documentation. No additional data will be collected for the study. All parameters will be obtained exclusively from existing clinical, radiological, procedural, and pathological routine care data.

—

Secondary

Measure	Time frame
• Procedure duration • Number of biopsies taken • Diagnostic yield per sample • Number of biopsies until the first positive sample • Ratio of diagnostic samples to total samples taken	—

Countries

Germany

Contacts

Public ContactHruy Menghesha

Universitätsklinikum Bonn

hruy.menghesha@ukbonn.de+4922828755125

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026