Lung CancerNCT07830095
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies
A study testing 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- Pathologically confirmed non-small cell lung cancer, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3; or metastatic lung tumors with the primary lesion well controlled, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
- Determined to be unsuitable for or unwilling to undergo surgery and radiotherapy.
- Determined to be unsuitable for or unwilling to undergo antitumor drug therapy.
- Considered technically feasible for robotic-assisted bronchoscopy-guided cryoablation of the target lesion(s).
- Provided written informed consent after being fully informed of the study procedures, potential benefits, and risks.
Who cannot join
- Unable to tolerate or unwilling to undergo general anesthesia.
- Contraindications to bronchoscopy or unwillingness to undergo bronchoscopy.
- Receipt of any form of local tumor therapy to the target lesion(s) within 6 months before the procedure.
- Evidence of intrathoracic lymph node metastases or extrathoracic metastases within 1 month before the procedure, except for extrathoracic metastases that had been effectively controlled by local treatment.
- Severe bleeding tendency or uncorrectable coagulation abnormalities, including a platelet count <50 × 10^9/L, prothrombin time >18 s, or prothrombin activity <40%.
- Anticoagulant or antiplatelet therapy not discontinued for the required duration before the procedure.
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- Severe hepatic or renal dysfunction considered by the investigator to preclude participation in the study.
- Uncontrolled infectious disease.
- Severe concomitant pulmonary disease, including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis with emphysema, atelectasis, or pulmonary hypertension, considered by the investigator to preclude participation in the study.
- Acute cardiovascular or cerebrovascular events, such as acute ischemic stroke or acute coronary syndrome, within 3 months before enrollment.
- A history of severe cardiac dysfunction and/or severe cardiac arrhythmia.
- Participation in another clinical trial involving treatment within the previous 3 months or concurrent participation in another clinical trial involving treatment.
- Pregnancy or lactation, or plans to become pregnant during the study period;
- Any other condition considered by the investigator to make the patient unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Feasibility Study on 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies: A Prospective, Multicenter, Single-Arm Clinical Study (BRIDGE Study)
The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
Read the detailed description
This is a prospective, multicenter, single-arm, and open-label clinical study. In this study, 15 patients will be enrolled to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
- Conditions
- Lung Cancer
- Being tested
- 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided CryoablationProcedure or surgery
All procedures will be performed under general anesthesia with endotracheal intubation. The operator will remotely manipulate the control console to navigate the robotic bronchoscope to the target bronchus. For lesions with no ideal bronchial access, a tunnel to the target lesion will be established by needle puncture. Radial endobronchial ultrasound (rEBUS) may be selectively used to identify and confirm the lesion location. The cryoablation probe will be advanced into the lesion through the bronchus or the established tunnel. After confirming the position of the cryoablation probe using cone-beam computed tomography (CBCT), cryoablation will be performed. Immediately after cryoablation, CBCT will be performed to evaluate the spatial relationship between the ablation zone and the target lesion. An imaging safety margin extending at least 5 mm beyond the margin of the target lesion will serve as an important criterion for technical success.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary malignancies | Experimental | 15 patients with pulmonary malignancies who meet the inclusion and exclusion criteria will be prospectively enrolled. 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation will be performed to treat the lesions. Receives: Procedure: 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate (Lesion Level)
The proportion of lesions achieving effective ablation under 5G-enabled remote robotic-assisted bronchoscopy guidance among all lesions that undergo ablation. Effective ablation is defined as an immediate post-procedural imaging finding demonstrating an ablation zone extending at least 5 mm beyond the margin of the target lesion.
Measured: Immediately after procedure
Secondary outcomes (9)
Complete Ablation Rate at 6 Months (Lesion Level)
The proportion of lesions that maintain complete ablation at 6 months after transbronchial cryoablation among all lesions that undergo ablation.
Measured: 6 months
Complete Ablation Rate at 12 Months (Lesion Level)
The proportion of lesions that maintain complete ablation at 12 months after transbronchial cryoablation among all lesions that undergo ablation.
Measured: 12 months
Intrapulmonary Progression-Free Survival Rate at 6 Months (Patient Level)
The proportion of patients without intrapulmonary disease progression at 6 months after transbronchial cryoablation among all patients who undergo ablation. Absence of intrapulmonary progression is defined as maintenance of imaging-confirmed non-progression of the treated lesion(s), absence of hilar lymph node metastasis, and absence of new lesions.
Measured: 6 months
Intrapulmonary Progression-Free Survival Rate at 12 Months (Patient Level)
The proportion of patients without intrapulmonary disease progression at 12 months after transbronchial cryoablation among all patients who undergo ablation. Absence of intrapulmonary progression is defined as maintenance of imaging-confirmed non-progression of the treated lesion(s), absence of hilar lymph node metastasis, and absence of new lesions.
Measured: 12 months
Overall Survival Rate at 12 Months (Patient Level)
The proportion of patients who remain alive at 12 months after transbronchial cryoablation among all patients who undergo ablation.
Measured: 12 months
Remote Image Transmission Latency
Remote image transmission latency is defined as the sum of local image latency, network transmission latency, and image encoding/decoding latency.
Measured: Immediately after procedure
Remote Control Latency
Remote control latency is defined as the sum of control computation latency, mechanical response latency, and network transmission latency.
Measured: Immediately after procedure
Packet Loss Rate
Packet loss rate is calculated as the number of lost data packets divided by the total number of data packets transmitted by the sender.
Measured: Immediately after procedure
Safety (Patient Level)
The incidence of device- or ablation-related adverse events occurring intraoperatively or within 1 month after the procedure.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830095
- Sponsor's protocol ID
- SHCHE202604
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies: A Prospective, Multicenter, Single-Arm Clinical Study (BRIDGE Study)
- ClinicalTrials.gov ID
- NCT07830095
- Acronym / sponsor ID
- SHCHE202604
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 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.
The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
Detailed description
This is a prospective, multicenter, single-arm, and open-label clinical study. In this study, 15 patients will be enrolled to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary malignancies | Experimental | Procedure: 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation15 patients with pulmonary malignancies who meet the inclusion and exclusion criteria will be prospectively enrolled. 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation will be performed to treat the lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Pathologically confirmed non-small cell lung cancer, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3; or metastatic lung tumors with the primary lesion well controlled, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
- Determined to be unsuitable for or unwilling to undergo surgery and radiotherapy.
- Determined to be unsuitable for or unwilling to undergo antitumor drug therapy.
Key exclusion criteria (14 listed)
- Unable to tolerate or unwilling to undergo general anesthesia.
- Contraindications to bronchoscopy or unwillingness to undergo bronchoscopy.
- Receipt of any form of local tumor therapy to the target lesion(s) within 6 months before the procedure.
- Evidence of intrathoracic lymph node metastases or extrathoracic metastases within 1 month before the procedure, except for extrathoracic metastases that had been effectively controlled by local treatment.
- Severe bleeding tendency or uncorrectable coagulation abnormalities, including a platelet count <50 × 10^9/L, prothrombin time >18 s, or prothrombin activity <40%.
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 |
|---|---|---|
| 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided CryoablationAll procedures will be performed under general anesthesia with endotracheal intubation. The operator will remotely manipulate the control console to navigate the robotic bronchoscope to the target bronchus. For lesions with no ideal bronchial access, a tunnel to the target lesion will be established by needle puncture. Radial endobronchial ultrasound (rEBUS) may be selectively used to identify and confirm the lesion location. The cryoablation probe will be advanced into the lesion through the bronchus or the established tunnel. After confirming the position of the cryoablation probe using cone-beam computed tomography (CBCT), cryoablation will be performed. Immediately after cryoablation, CBCT will be performed to evaluate the spatial relationship between the ablation zone and the target lesion. An imaging safety margin extending at least 5 mm beyond the margin of the target lesion will serve as an important criterion for technical success. | Procedure or surgery | Patients with pulmonary malignancies |
Primary outcome
Technical Success Rate (Lesion Level)
Time frame: Immediately after procedure
The proportion of lesions achieving effective ablation under 5G-enabled remote robotic-assisted bronchoscopy guidance among all lesions that undergo ablation. Effective ablation is defined as an immediate post-procedural imaging finding demonstrating an ablation zone extending at least 5 mm beyond the margin of the target lesion.
9 secondary outcomes
Complete Ablation Rate at 6 Months (Lesion Level)
Time frame: 6 months
Complete Ablation Rate at 12 Months (Lesion Level)
Time frame: 12 months
Intrapulmonary Progression-Free Survival Rate at 6 Months (Patient Level)
Time frame: 6 months
Intrapulmonary Progression-Free Survival Rate at 12 Months (Patient Level)
Time frame: 12 months
Overall Survival Rate at 12 Months (Patient Level)
Time frame: 12 months
Remote Image Transmission Latency
Time frame: Immediately after procedure
Remote Control Latency
Time frame: Immediately after procedure
Packet Loss Rate
Time frame: Immediately after procedure
Safety (Patient Level)
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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.
Jiayuan Sun principal investigator
Shanghai Chest 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 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation in people with Lung Cancer, run by Shanghai Chest Hospital 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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun (+86-021-22200000 ext. 1511, xkyyjysun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success Rate (Lesion Level) (time frame: Immediately after procedure). 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 14 Oct 2026.