ClinicalTrials.gg
CompletedNCT07924176Updated Nov 9, 2026

Robot-Assisted Bronchoscopy for Lung Lesion Biopsy and Ablation

An interventional study of Robot-Assisted Bronchoscopic Biopsy and Robot-Assisted Transbronchial Ablation in Pulmonary Lesions, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Apr 2025, registered Oct 2026).
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study evaluates whether robot-assisted bronchoscopy can be used successfully and safely to obtain tissue samples and perform local treatment of lung lesions at Shanghai Pulmonary Hospital, China. Lung lesions are abnormal areas seen on lung scans. Bronchoscopy uses a thin, flexible tube passed through the airways to reach these areas. A biopsy collects tissue to help establish a diagnosis. Ablation is a local treatment intended to destroy targeted abnormal tissue.

The prospective part of the study has three stages: biopsy, an initial evaluation of ablation, and biopsy followed by ablation during the same anesthesia session. Adults enter the appropriate group according to their clinical needs and suitability for the procedure, rather than by random assignment. The need for ablation is determined before the procedure. Imaging is used to confirm the positions of the lesion and instruments, and treatment may be adjusted or stopped if safety conditions are not met.

An exploratory comparison uses existing medical records of patients who underwent biopsy and ablation through the chest wall in separate procedures. Researchers compare this staged approach with biopsy and ablation performed through the airways in one session to explore differences in treatment completion time, time spent in hospital, and procedure duration.

The main outcome for the pathway comparison is the number of days from the first hospital admission to completion of the last planned ablation procedure. Other assessments include whether biopsy provides a diagnosis, whether planned ablation is completed, changes on follow-up scans, and procedure-related complications. After ablation, participants undergo computed tomography (CT) scans at 1 and 6 months, with an additional imaging assessment at either 9 or 12 months.

02

Conditions studied

  • Pulmonary Lesions
03

In context

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years;
  • CT-defined pulmonary lesions requiring tissue sampling or local ablation;
  • Suitability for the intended robotic bronchoscopic procedure, with acceptable procedural and anaesthetic risk;
  • Voluntary participation and written .

Exclusion criteria

Exclusion Criteria:

  • Inability to tolerate the intended procedure or required anaesthesia;
  • Unacceptable bleeding risk;
  • Absence of a safe procedural route or a lesion unsuitable for the intended procedure;
  • Refusal to participate.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Same-session group

    Procedure: Robot-Assisted Bronchoscopic Biopsy · Procedure: Robot-Assisted Transbronchial Ablation · Procedure: Same-Session Robot-Assisted Bronchoscopic Biopsy and Transbronchial Ablation

Interventions

  • ProcedureRobot-Assisted Bronchoscopic Biopsy

    Image-guided tissue sampling of pulmonary lesions using Ion shape-sensing robotic-assisted bronchoscopy.

  • ProcedureRobot-Assisted Transbronchial Ablation

    Image-guided transbronchial ablation of pulmonary lesions using Ion shape-sensing robotic-assisted bronchoscopy, with eligibility for ablation established before the procedure.

  • ProcedureSame-Session Robot-Assisted Bronchoscopic Biopsy and Transbronchial Ablation

    Image-guided biopsy and transbronchial ablation of pulmonary lesions using Ion shape-sensing robotic-assisted bronchoscopy during a single anaesthetic session.

06

What researchers measure

Primary outcomes

  1. Time from first hospital admission to completion of the last planned ablation

    Time frame: Periprocedural period.

07

Study locations

1 site
  • Shanghai Pulmonary Hospital
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2025 to primary completion in Apr 2025, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 9, 2026
StartActual
Apr 1, 2025
Primary completionActual
Apr 28, 2025
CompletionActual
Apr 28, 2026
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924176
Responsible party
Ye Gu (Deputy Director, Endoscopy Center, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
Nov 9, 2026
Start date
Apr 1, 2025
Primary completion
Apr 28, 2025
Completion
Apr 28, 2026
Last update
Nov 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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