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Multiple Pulmonary NodulesNCT07395362

Hybrid Robot-Assisted Percutaneous Ablation and Non-Intubated VATS for Multiple Pulmonary Nodules

A study testing Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery in people with Multiple Pulmonary Nodules, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety and feasibility of a predefined hybrid treatment strategy in patients with multiple pulmonary nodules who require surgical management of at least one dominant lesion. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Multiple Pulmonary Nodules
What is being tested?
Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
28 Feb 2026to 1 Oct 2026
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 85 years at the time of enrollment.
  • Presence of multiple pulmonary nodules identified on chest computed tomography (CT).
  • At least one dominant pulmonary lesion meeting standard indications for thoracoscopic surgical resection based on radiologic assessment.
  • At least one additional pulmonary nodule for which complete surgical resection is considered undesirable due to lung parenchyma preservation concerns or procedural risk, and deemed suitable for robot-assisted CT-guided percutaneous intervention.
  • Determined by a multidisciplinary team (MDT) to be an appropriate candidate for the predefined hybrid treatment strategy.
  • Eligible for non-intubated video-assisted thoracoscopic surgery based on preoperative anesthetic evaluation (ASA physical status I-III).
  • Ability to understand the study procedures and provide written informed consent.

Who cannot join

  • Pulmonary nodules located centrally or adjacent to major airways, major vessels, or the heart, where safe percutaneous intervention is not feasible.
  • Pure ground-glass nodules with a maximum diameter < 6 mm, for which active surveillance is recommended.
  • Clinical evidence of N1/N2 lymph node involvement or distant metastasis.
  • Severe cardiopulmonary disease, interstitial lung disease, or other conditions that preclude thoracoscopic surgery or anesthesia.
  • Coagulation disorders or ongoing anticoagulation therapy that cannot be safely discontinued.
  • Pregnancy or breastfeeding.
  • Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yudong Zhang, MD contact

+86 13168266675

yudongz834@gmail.com

China1 site
  • The First Affiliated Hospital of GZMU

    Guangzhou

    Yudong Zhang, +86 13168266675, yudongz834@gmail.com

Other trials in China

About this study

Official title: A Prospective Single-Arm Study Evaluating the Safety, Feasibility, and Perioperative Recovery of Robot-Assisted Percutaneous Ablation/Localization Combined With Non-Intubated Video-Assisted Thoracoscopic Surgery for Multiple Pulmonary Nodules

The goal of this clinical trial is to evaluate the safety and feasibility of a predefined hybrid treatment strategy in patients with multiple pulmonary nodules who require surgical management of at least one dominant lesion. The strategy combines robot-assisted CT-guided percutaneous ablation and/or localization with non-intubated video-assisted thoracoscopic surgery (NiVATS) performed during the same hospitalization.

The main questions this study aims to answer are:

Read more

Is the hybrid treatment strategy associated with an acceptable rate of perioperative serious complications?

Can the planned combination of robot-assisted percutaneous intervention and NiVATS be completed successfully in a real-world clinical setting?

Participants will:

Undergo preoperative evaluation and multidisciplinary assessment;

Receive robot-assisted CT-guided percutaneous ablation and/or localization for selected pulmonary nodules;

Undergo non-intubated video-assisted thoracoscopic surgery for resection of the dominant pulmonary lesion;

Be followed for perioperative outcomes and short-term recovery up to 30 days after surgery.

Read the detailed description

This is a prospective, single-arm interventional study conducted at a tertiary academic medical center. The study enrolls adult patients with multiple pulmonary nodules, including at least one dominant lesion that meets standard indications for thoracoscopic surgical resection and one or more additional nodules for which complete surgical resection is considered undesirable due to concerns regarding lung parenchymal preservation or procedural risk.

All participants receive a predefined hybrid treatment strategy during the same hospitalization. Selected secondary pulmonary nodules are managed using robot-assisted CT-guided percutaneous procedures, including localization, biopsy, and/or thermal ablation as clinically appropriate. Subsequently, the dominant lesion is resected using non-intubated video-assisted thoracoscopic surgery under spontaneous ventilation anesthesia. Conversion to conventional intubated anesthesia is permitted if clinically indicated.

The primary focus of this study is to assess perioperative safety and technical feasibility rather than comparative efficacy. Safety is evaluated by monitoring perioperative complications within 30 days after the procedure, while feasibility is assessed based on successful completion of the planned hybrid treatment strategy. Secondary observations include perioperative recovery parameters such as length of hospital stay, postoperative pain, and short-term clinical outcomes.

This study is designed to provide prospective evidence regarding the clinical applicability of a hybrid, lung parenchyma-preserving approach for the management of multiple pulmonary nodules within the framework of current surgical and interventional practice.

Being tested
Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery
Keywords
Multiple pulmonary nodules, Ground-glass nodules, Robot-assisted percutaneous ablation, CT-guided intervention, Non-intubated video-assisted thoracoscopic surgery NiVATS
Medical subject headings
Multiple Pulmonary Nodules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic SurgeryProcedure or surgery

    Also called Robot-assisted percutaneous ablation, CT-guided percutaneous localization, Non-intubated VATS, NiVATS

    This intervention consists of a predefined hybrid procedural strategy performed during the same hospitalization. Selected pulmonary nodules are managed using robot-assisted CT-guided percutaneous procedures, including localization, biopsy, and/or thermal ablation as clinically appropriate. Subsequently, the dominant pulmonary lesion is resected using non-intubated video-assisted thoracoscopic surgery under spontaneous ventilation anesthesia. Conversion to conventional intubated anesthesia is permitted if clinically indicated.

Study groups in NCT07395362
Study groupRoleWhat they receive
Hybrid Robot-Assisted Percutaneous Intervention Plus Non-Intubated VATSExperimentalParticipants in this single-arm study receive a predefined hybrid treatment strategy during the same hospitalization. The intervention consists of robot-assisted CT-guided percutaneous procedures (including localization, biopsy, and/or thermal ablation as clinically appropriate) for selected pulmonary nodules, followed by non-intubated video-assisted thoracoscopic surgery for resection of the dominant pulmonary lesion. Conversion to conventional intubated anesthesia is permitted if clinically indicated.
Receives: Procedure: Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative Serious Complications

    The proportion of participants who experience serious perioperative complications within 30 days after the procedure, defined as complications of Clavien-Dindo grade III or higher, including events requiring surgical, endoscopic, or radiologic intervention, intensive care management, or resulting in death.

    Measured: Within 30 days after the procedure

Secondary outcomes (1)
  1. Successful completion rate of the planned hybrid treatment strategy

    Technical feasibility is defined as the proportion of participants in whom the planned hybrid treatment strategy-robot-assisted CT-guided percutaneous intervention followed by non-intubated video-assisted thoracoscopic surgery-is successfully completed without unplanned abandonment of the procedure. Conversion to conventional intubated anesthesia is permitted and will be recorded.

    Measured: From the start of the percutaneous intervention to completion of the planned hybrid procedure during the same hospitalization, assessed up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start28 Feb 2026 (estimated)
  3. Primary completion28 Aug 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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
Model description
This is a prospective, single-arm study in which all enrolled participants receive a predefined hybrid treatment strategy combining robot-assisted percutaneous intervention and non-intubated video-assisted thoracoscopic surgery during the same hospitalization.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395362
Sponsor's protocol ID
GZMUFAH-MLN-HYBRID-2026-01
Status last verified
Jan 2026
First submitted
25 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results reported in publications, including baseline characteristics, perioperative variables, and outcome measures, will be shared. No direct identifiers will be included. Data not relevant to the primary and secondary outcomes will not be shared.

Publications

  • Ye X, Fan W, Wang Z, Wang J, Wang H, Niu L, Fang Y, Gu S, Liu L, Liu B, Zhuang Y, Wei Z, Li X, Li X, Li Y, Li C, Yang X, Yang W, Yang P, Lin Z, Meng Z, Hu K, Liu C, Huang Y, Huang G, Huang K, Peng Z, Han Y, Jin Y, Lei G, Zhai B, Li H, Pan J, Filippiadis D, Kelekis A, Pua U, Futacsi B, Yumchinserchin N, Iezzi R, Tang A, Roy SH. Clinical practice guidelines on image-guided thermal ablation of primary and metastatic lung tumors (2022 edition). J Cancer Res Ther. 2022 Sep;18(5):1213-1230. doi: 10.4103/jcrt.jcrt_880_22.

    PubMed 36204866
  • Chen H, Kim AW, Hsin M, Shrager JB, Prosper AE, Wahidi MM, Wigle DA, Wu CC, Huang J, Yasufuku K, Henschke CI, Suzuki K, Tailor TD, Jones DR, Yanagawa J. The 2023 American Association for Thoracic Surgery (AATS) Expert Consensus Document: Management of subsolid lung nodules. J Thorac Cardiovasc Surg. 2024 Sep;168(3):631-647.e11. doi: 10.1016/j.jtcvs.2024.02.026. Epub 2024 Jun 14.

    PubMed 38878052
  • MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.

    PubMed 28240562

Questions about this trial

What is this clinical trial studying?

A study testing Hybrid Robot-Assisted Percutaneous Intervention and Non-Intubated Video-Assisted Thoracoscopic Surgery in people with Multiple Pulmonary Nodules, run by The First Affiliated Hospital of Guangzhou Medical University 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 7 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 9 Feb 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 Yudong Zhang, MD (+86 13168266675, yudongz834@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative Serious Complications (time frame: Within 30 days after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07395362, which also lists 3 linked publications.

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 9 Feb 2026.

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