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New treatment option for Lung Malignancies
Official title Exploratory Trial of Navigational Bronchoscopy-Guided Cryoablation in Lung Cancer Treatment
ClinicalTrials.gov ID: NCT07301411
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- The maximum diameter of the tumor is ≤3 cm;
- The number of tumors is ≤3 (no limit for multiple primary lung cancer people);
- people who decline or are deemed unsuitable for surgery per multidisciplinary team's discretion;
You likely can't join if
- people with diffuse lesions in both lungs whose condition cannot be improved by ablation treatment;
- people whose examination within 1 month prior to treatment suggests intrathoracic lymph node metastasis or extrapulmonary metastasis (except for...
- With reference to the Guidelines for the Application of Diagnostic Flexible Bronchoscopy for Adults (2019 Edition) [1], people with contraindications...
- people who are using antiplatelet or anticoagulant drugs and cannot be properly managed before treatment (properly managed including clopidogrel...
- people with severe bleeding tendency, uncorrectable coagulation dysfunction;
- people with electrically or magnetically activated devices implanted or metallic implants (non-titanium);
See the full eligibility criteria
Who can join
- 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...
- The maximum diameter of the tumor is ≤3 cm;
- The number of tumors is ≤3 (no limit for multiple primary lung cancer people);
- people who decline or are deemed unsuitable for surgery per multidisciplinary team's discretion;
- people who decline or are deemed unsuitable for radiotherapy per investigator's discretion;
- people whose lesions to be ablated are assessed to be feasible for bronchoscopy-guided cryoablation per investigator's discretion;
- people who are willing to participate in the study and sign the written informed consent.
What rules you out
- people with diffuse lesions in both lungs whose condition cannot be improved by ablation treatment;
- people 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], people with contraindications for bronchoscopy, such as acute myocardial infarction (within 4...
- people 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...
- people with severe bleeding tendency, uncorrectable coagulation dysfunction;
- people with electrically or magnetically activated devices implanted or metallic implants (non-titanium);
- people 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...
- The people with Eastern Cooperative Oncology Group (ECOG) performance status score of \>2 (See Appendix 1 for details of ECOG scoring criteria);
- people having received radiotherapy within the past 6 months for the lesion to be ablated;
- people expected to participate in any other experimental or invasive clinical study within 12 months of the ablation procedure;
- people 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...
- Those with epilepsy, psychiatric history or cognitive impairment;
- Pregnant, lactating women, and people who are unwilling to use reasonable contraception during the clinical trial;
- people who had participated or are participating in a drug clinical trial within 3 months (participants in non-treatment trials can be included), or who had participated or are participating in another medical device...
- Other circumstances which are considered by the investigator not suitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Shatin, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Shatin, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.