Exploratory Trial of Navigational Bronchoscopy-Guided Cryoablation in Lung Cancer Treatment

NCT07301411 | Recruiting FDA Device

• 1 other identifier: CTP-002
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

This clinical trial is an exploratory clinical trial with two cohorts: Cohort 1: aiming to conduct a preliminary evaluation of the effectiveness and safety of the Navigational Bronchoscopy System and the Bronchoscope and Accessories (manufactured by Noah) in combination with the cryoablation therapy devices for the treatment of lung malignancies. Cohort 2: aiming to conduct a preliminary evaluation of the effectiveness and safety of the Navigational Bronchoscopy System and the Bronchoscope and Accessories (manufactured by Puli Ark) in combination with the cryoablation therapy devices for the treatment of lung malignancies. The overall objective of this study is to conduct a preliminary evaluation of the effectiveness and safety of navigational bronchoscopy - guided cryoablation therapy of the lungs through the above two cohorts.

Conditions

Lung Malignancies

Keywords

Navigational Bronchoscopy System; Lung Malignancies; Cryoablation

Outcome Measures

Primary Outcomes (1)

• Technical success rate (ablation lesion level)

  Definition of technical success: Immediately following the procedure (no more than 30 minutes after completion of all ablation deliveries), the cone-beam computerized tomography (CBCT) imaging (evaluated by treating investigator) shows that the target lesion is covered completely by the ablation zone (i.e., the ablation zone completely overlaps or encompasses target tumor plus an ablative margin (a minimum of 5 mm ablative margin).

  Immediately following the procedure (no more than 30 minutes after completion of all ablation deliveries)

Secondary Outcomes (5)

• Technique efficacy rate at 3 months after treatment (ablation lesion level)

  3 months after ablation treatment

• Disease control rate

  At 3 months follow-ups.

• Navigation success rate

  During the cryoablation procedure

• Quality of life score

  At screening period/baseline, 1 month post-treatment, and 3 months post-treatment follow-up

• Device performance evaluation

  On the day of the ablation procedure

Other Outcomes (3)

• Adverse events (AEs) / Serious Adverse Events (SAEs)

  * Screening period/ Baseline (Day -30 to Day 0) * Treatment period / the day of ablation procedure (Day 0) * Day 1 post-treatment, within 24 hours after treatment * 1 month post-treatment * 3 months post-treatment

• Device-related AEs / device-related SAEs

  * Treatment period / the day of ablation procedure (Day 0) * Day 1 post-treatment, within 24 hours after treatment * 1 month post-treatment * 3 months post-treatment

• Complications

  * Treatment period / the day of ablation procedure (Day 0) * Day 1 post-treatment, within 24 hours after treatment * 1 month post-treatment * 3 months post-treatment

Study Arms (1)

An exploratory clinical trial with two cohorts

EXPERIMENTAL

Cohort1: Enrolled subjects will undergo bronchoscopy-guided cryoablation procedure for treating malignant lung nodules in Shanghai Chest Hospital, China. Cohort2: Enrolled subjects will undergo bronchoscopy-guided cryoablation procedure for treating malignant lung nodules at the Prince of Wales Hospital of the Chinese University of Hong Kong. The two cohorts differ in the manufacturer of the bronchoscope and accessories used at each site.

Device: Cryoablation Therapy

Interventions

Cryoablation Therapy DEVICE

Navigational Bronchoscopy System and Bronchoscope and Accessories in Combination with Cryoablation Therapy Device.

Also known as: Navigational Bronchoscopy System, Bronchoscope and Accessories, Cryoablation Therapy Device

An exploratory clinical trial with two cohorts

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years old (inclusive), male or female;
• Primary peripheral lung cancer, with pre-treatment staging examination indicating clinical stage T1N0M0, IA (including new onset and multiple primary lesions after treatment); or metastatic lung tumor, with the primary lesion completely removed or well controlled;
• The maximum diameter of the tumor is ≤3 cm;
• The number of tumors is ≤3 (no limit for multiple primary lung cancer subjects);
• Subjects who decline or are deemed unsuitable for surgery per multidisciplinary team's discretion;
• Subjects who decline or are deemed unsuitable for radiotherapy per investigator's discretion;
• Subjects whose lesions to be ablated are assessed to be feasible for bronchoscopy-guided cryoablation per investigator's discretion;
• Subjects who are willing to participate in the study and sign the written informed consent.

You may not qualify if:

• Subjects with diffuse lesions in both lungs whose condition cannot be improved by ablation treatment;
• Subjects whose examination within 1 month prior to treatment suggests intrathoracic lymph node metastasis or extrapulmonary metastasis (except for those whose extrapulmonary metastasis is controlled by local treatment);
• With reference to the Guidelines for the Application of Diagnostic Flexible Bronchoscopy for Adults (2019 Edition) \[1\], subjects with contraindications for bronchoscopy, such as acute myocardial infarction (within 4 weeks), active massive hemoptysis, platelet count \< 60×109/L, malignant arrhythmia, unstable angina, severe cardiopulmonary insufficiency, hypertensive crisis, severe pulmonary hypertension, intracranial hypertension, acute cerebrovascular events (i.e. cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, intracranial venous thrombosis, etc.), aortic dissection, aortic aneurysm, and systemic extreme failure;
• Subjects who are using antiplatelet or anticoagulant drugs and cannot be properly managed before treatment (properly managed including clopidogrel terminated 7 days before treatment, ticagrelor terminated 5 days before treatment, warfarin terminated 5 days before treatment, low molecular weight heparin terminated 24 hours before treatment, etc.);
• Subjects with severe bleeding tendency, uncorrectable coagulation dysfunction;
• Subjects with electrically or magnetically activated devices implanted or metallic implants (non-titanium);
• Subjects with other tumors and extensive metastasis, with an expected survival of less than 12 months;
• Poor general condition (e.g. systemic multiple metastases, severe infection, high fever), infectious and radioactive inflammation around the focus, obvious cachexia, serious dysfunction of important organs, severe anemia and nutritional metabolism disorder that cannot be improved in a short time;
• The subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of \>2 (See Appendix 1 for details of ECOG scoring criteria);
• Subjects having received radiotherapy within the past 6 months for the lesion to be ablated;
• Subjects expected to participate in any other experimental or invasive clinical study within 12 months of the ablation procedure;
• Subjects with a history of active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive) or, in the investigator's judgment, conditions that may affect the subject's treatment;
• Those with epilepsy, psychiatric history or cognitive impairment;
• Pregnant, lactating women, and subjects who are unwilling to use reasonable contraception during the clinical trial;
• Subjects who had participated or are participating in a drug clinical trial within 3 months (participants in non-interventional trials can be included), or who had participated or are participating in another medical device clinical trial within 1 month (participants in non-interventional trials can be included);

Sponsors & Collaborators

• Tianjin Puli Ark Medical Technology Co., Ltd.: lead

Study Sites (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopes

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Calvin Ng

  Chinese University of Hong Kong, Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Jia

CONTACT

+86 13436311329; dandanjia@pulimed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 24, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (1)