ClinicalTrials.gg
Not yet recruitingNCT07830095Updated Nov 6, 2026

5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies

An interventional study of 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation in Lung Cancer, sponsored by Shanghai Chest Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Start date movedEligibility revised+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Lung Cancer

Browse trials for

03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 15 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.

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

04

Who can participate

The criteria were revised on the registry on Nov 6, 2026. See what changed

Ages eligible
18 Years and older
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

  1. Age ≥18 years.
  2. confirmed or highly suspected following preoperative multidisciplinary discussion to have either: (a) primary peripheral lung cancer, with preoperative staging investigations indicating clinical stage T1N0M0, stage IA, including newly developed primary lung cancer after previous lung cancer surgery and multiple primary lung cancers; or (b) lung tumors with the primary tumor well controlled. The target lesions must have a maximum diameter ≤3 cm, with no more than 3 lesions planned for ablation. For patients without a preoperative pathological diagnosis, must be confirmed by intraoperative and pathological assessment, and all other conditions for ablation must be met before cryoablation is performed during the same procedure.
  3. (ECOG) performance status score ≤2.
  4. Determined by multidisciplinary assessment to be unsuitable for or unwilling to undergo surgery and radiotherapy.
  5. Considered technically feasible for robotic-assisted bronchoscopy-guided cryoablation of the target lesion(s).
  6. Provided written after being fully informed of the study procedures, potential benefits, and risks.

Exclusion criteria

Exclusion Criteria:

  1. Unable to tolerate or unwilling to undergo general anesthesia.
  2. to bronchoscopy or unwillingness to undergo bronchoscopy.
  3. Receipt of any form of local tumor therapy to the target lesion(s) within 6 months before the procedure.
  4. Evidence of intrathoracic lymph node or extrathoracic metastases within 1 month before the procedure, except for extrathoracic metastases that had been effectively controlled by local treatment.
  5. Severe bleeding tendency or uncorrectable coagulation abnormalities, including a count \<50 × 10\^9/L, >18 s, or prothrombin activity \<40%.
  6. Anticoagulant or antiplatelet therapy not discontinued for the required duration before the procedure.
  7. Severe hepatic or renal dysfunction considered by the investigator to preclude participation in the study.
  8. Uncontrolled infectious disease.
  9. 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.
  10. Acute cardiovascular or cerebrovascular events, such as acute ischemic stroke or acute coronary syndrome, within 3 months before enrollment.
  11. A history of severe cardiac dysfunction and/or severe cardiac arrhythmia.
  12. Participation in another clinical trial involving treatment within the previous 3 months or concurrent participation in another clinical trial involving treatment.
  13. Pregnancy or lactation, or plans to become pregnant during the study period;
  14. Any other condition considered by the investigator to make the patient unsuitable for enrollment.
Terms in these criteria, in plain language(9)

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Patients with confirmed or suspected pulmonary malignancies

    Fifteen patients who meet the inclusion and exclusion criteria will be prospectively enrolled. Eligible patients with a preoperative pathological diagnosis will undergo 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation. Patients without a preoperative pathological diagnosis will first undergo biopsy and intraoperative pathological assessment. Cryoablation will proceed during the same procedure only if malignancy is confirmed and all other conditions for ablation are met.

    Procedure: 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation

Interventions

  • Procedure5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation

    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. Needle puncture may establish access if no suitable bronchial route is available. rEBUS may assist localization. Patients without a preoperative pathological diagnosis will undergo biopsy and intraoperative pathological assessment. Cryoablation will proceed only if malignancy is confirmed and all other eligibility and safety conditions are met; otherwise, no ablation will be performed. All biopsy specimens will undergo formal pathological examination. The cryoprobe will be positioned under CBCT guidance. Immediate post-ablation CBCT will assess coverage, with an ablation margin of at least 5 mm beyond the target lesion required for technical success.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after procedure

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 12 months

  3. 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.

    Time frame: 6 months

  4. 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.

    Time frame: 12 months

  5. 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.

    Time frame: 12 months

  6. 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.

    Time frame: Immediately after procedure

  7. Remote Control Latency

    Remote control latency is defined as the sum of control computation latency, mechanical response latency, and network transmission latency.

    Time frame: Immediately after procedure

  8. 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.

    Time frame: Immediately after procedure

  9. Safety (Patient Level)

    The incidence of device-, biopsy-, or ablation-related adverse events occurring intraoperatively or within 1 month after the procedure among all participants who undergo study-related procedures, including those who undergo biopsy without subsequent ablation.

    Time frame: 1 month

07

Study locations

1 site
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.

Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 1 month is below that.

Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 6, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartEst.
Nov 13, 2026was Sep 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2027
Last update
Nov 6, 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.
Start date
Sep 30, 2026→Nov 13, 2026
Nov 6, 2026
Eligibility
2 inclusion criteria edited, 1 removed
What changed in the criteria
Inclusion criteria
  • ChangedBefore 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.Now Pathologically confirmed or highly suspected following preoperative multidisciplinary discussion to have either: (a) primary peripheral lung cancer, with preoperative staging investigations indicating clinical stage T1N0M0, stage IA, including newly developed primary lung cancer after previous lung cancer surgery and multiple primary lung cancers; or (b) metastatic lung tumors with the primary tumor well controlled. The target lesions must have a maximum diameter ≤3 cm, with no more than 3 lesions planned for ablation. For patients without a preoperative pathological diagnosis, malignancy must be confirmed by intraoperative biopsy and pathological assessment, and all other conditions for ablation must be met before cryoablation is performed during the same procedure.
  • EditedDetermined by multidisciplinary assessment to be unsuitable for or unwilling to undergo surgery and radiotherapy.
  • RemovedDetermined to be unsuitable for or unwilling to undergo antitumor drug therapy.
Nov 6, 2026
Interventions
Arm changed Patients with pulmonary malignancies→Patients with confirmed or suspected pulmonary malignancies
Nov 6, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionSafety (Patient Level): how it is measured was reworded
Nov 6, 2026
Show all 2 updates
  1. Nov 6, 2026
    Start date Sep 30, 2026→Nov 13, 2026
    Eligibility 2 inclusion criteria edited, 1 removed
    What changed in the criteria
    Inclusion criteria
    • ChangedBefore 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.Now Pathologically confirmed or highly suspected following preoperative multidisciplinary discussion to have either: (a) primary peripheral lung cancer, with preoperative staging investigations indicating clinical stage T1N0M0, stage IA, including newly developed primary lung cancer after previous lung cancer surgery and multiple primary lung cancers; or (b) metastatic lung tumors with the primary tumor well controlled. The target lesions must have a maximum diameter ≤3 cm, with no more than 3 lesions planned for ablation. For patients without a preoperative pathological diagnosis, malignancy must be confirmed by intraoperative biopsy and pathological assessment, and all other conditions for ablation must be met before cryoablation is performed during the same procedure.
    • EditedDetermined by multidisciplinary assessment to be unsuitable for or unwilling to undergo surgery and radiotherapy.
    • RemovedDetermined to be unsuitable for or unwilling to undergo antitumor drug therapy.
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionSafety (Patient Level): how it is measured was reworded
    Interventions Arm changed Patients with pulmonary malignancies→Patients with confirmed or suspected pulmonary malignancies
    + 1 other change: verification date
  2. Oct 14, 2026
    Minor edits only
    + 1 other change: verification date

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 ↗

09

Registry details

Key details

Study ID
NCT07830095
Responsible party
Jiayuan Sun (Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital) — Principal investigator
First posted
Sep 21, 2026
Start date
Nov 13, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Jiayuan Sun
Contact
xkyyjysun@163.com
+86-021-22200000 ext. 1511
Jiayuan Sun
principal investigator · Shanghai Chest Hospital

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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