Peripheral Pulmonary NodulesNCT07642986
Diagnosis and Treatment of Lung Lesions
A study testing A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB) in people with Peripheral Pulmonary Nodules and Ablation Techniques, run by Jisong Zhang at 1 site in China.
Trial summary
To evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Nodules, Ablation Techniques
- What is being tested?
- A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
About this study
Official title: A Study on the Feasibility and Safety of Single-Session Robot-Assisted Bronchoscopy for Diagnosis and Ablation of Pulmonary Lesions
To evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).
Read the detailed description
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).
- Conditions
- Peripheral Pulmonary Nodules, Ablation Techniques
- Being tested
- A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)
- Keywords
- Peripheral pulmonary lesions, Tumor ablation, Robotic-assisted bronchoscopy, Single-session procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| One-stop treatment group | Experimental | 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. Receives: Procedure: A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navigation success rate
Measured: Perioperatively
Ablation success rate
Measured: Perioperatively
Post-operative complication rate
Measured: Immediately after the procedure through hospital discharge
Secondary outcomes (3)
Diagnostic yield
Measured: Perioperatively
Postoperative hospital stay
Measured: Immediately after the procedure through hospital discharge
Local progression-free survival rate
Measured: Three months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Pulmonary NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jisong Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Responsible party
- Sponsor-investigator, Jisong Zhang, Sir Run Run Shaw Hospital
- Investigators
- Jisong Zhang, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642986
- Sponsor's protocol ID
- SirRRSH-2024-RABone
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Feasibility and Safety of Single-Session Robot-Assisted Bronchoscopy for Diagnosis and Ablation of Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT07642986
- Acronym / sponsor ID
- SirRRSH-2024-RABone
- Conditions
- Peripheral Pulmonary Nodules, Ablation Techniques
- Keywords
- Peripheral pulmonary lesions, Tumor ablation, Robotic-assisted bronchoscopy, Single-session procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jisong ZhangUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One-stop treatment group | Experimental | Procedure: A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)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. | Procedure or surgery | One-stop treatment group |
Primary outcome
Navigation success rate
Time frame: Perioperatively
Ablation success rate
Time frame: Perioperatively
Post-operative complication rate
Time frame: Immediately after the procedure through hospital discharge
3 secondary outcomes
Diagnostic yield
Time frame: Perioperatively
Postoperative hospital stay
Time frame: Immediately after the procedure through hospital discharge
Local progression-free survival rate
Time frame: Three months after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jisong Zhang, MD principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB) in people with Peripheral Pulmonary Nodules and Ablation Techniques, run by Jisong Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navigation success rate (time frame: Perioperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.