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Completed

NCT Number: NCT07642986

Diagnosis and Treatment of Lung Lesions

To evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).

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Key information

Conditions

Peripheral Pulmonary Nodules Ablation Techniques

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

About this study

The increasing detection of peripheral pulmonary lesions (PPLs) necessitates effective, lung-sparing therapies. For inoperable patients, current guidelines dictate a staged workflow involving diagnostic biopsy followed by a separately scheduled ablation. This study aims to evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Have peripheral pulmonary lesions (PPLs).
  • Meet at least one of the following conditions: (1) Deemed medically inoperable due to surgical intolerance; (2) Have newly developed or residual nodules after previous lung cancer surgery; (3) Present with multiple bilateral pulmonary nodules; or (4) Explicitly refuse surgical resection.

Exclusion criteria

  • Centrally located tumors invading the main bronchi.
  • Uncorrectable coagulopathy.
  • Evidence of advanced nodal (N2/N3) or distant metastatic disease (unless the PPL represented an oligometastatic lesion targeted with curative intent).

Treatment and study plan

A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)

Procedure

Inoperable patients underwent synchronous biopsy and ablation under RAB and cone-beam CT guidance. Following confirmation of atypical cells by rapid on-site evaluation (ROSE), individualized ablation (cryoablation, radiofrequency ablation, or synergistic irreversible electroporation) was performed in the same anesthetic setting.

Primary outcomes

  1. Navigation success rate

    Time frame: Perioperatively

  2. Ablation success rate

    Time frame: Perioperatively

  3. Post-operative complication rate

    Time frame: Immediately after the procedure through hospital discharge

Secondary outcomes

  1. Diagnostic yield

    Time frame: Perioperatively

  2. Postoperative hospital stay

    Time frame: Immediately after the procedure through hospital discharge

  3. Local progression-free survival rate

    Time frame: Three months after the operation

Sponsors and collaborators

Lead sponsor

Jisong Zhang

Other

Collaborators

  • Sir Run Run Shaw Hospital

Registry information

Official study title

A Study on the Feasibility and Safety of Single-Session Robot-Assisted Bronchoscopy for Diagnosis and Ablation of Pulmonary Lesions

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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