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Trial Title:
Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules
NCT ID:
NCT06530667
Condition:
Lung Neoplasm Malignant
Secondary Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Multiple Pulmonary Nodules
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
broadband collaborative pulse ablation
Description:
Via CT guided, patients with malignant pulmonary nodules would be treated by broadband
collaborative pulse ablation
Arm group label:
treatment group
Summary:
Effectiveness safety and feasibility of the broadband collaborative pulse ablation
instrument in treating malignant pulmonary nodules
Detailed description:
This clinical trial is to observe the safety and efficacy of the broadband synergistic
pulse ablation device for treating malignant pulmonary nodules, and to provide reference
data for the development of formal trials.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: between 18 and 70 years old with no gender limitation;
2. Malignant pulmonary nodules diagnosed by cytology and/or histopathology, or the
number of tumors ≤3. The pulmonary nodules were oligometastatic and the primary
lesions were stable, with no uncontrolled metastasis to other sites;
3. Surgery is not available or the patient refuses surgical treatment;
4. Nodules' Maximum diameter≤2cm;
5. ECOG score≤2;
6. Patients understood the trial procedure and voluntarily signed informed consent.
Exclusion Criteria:
1. An electronic device is implanted near the target area or an implanted pacemaker or
defibrillator is present in the body;
2. Coagulation dysfunction with severe bleeding tendency and short-term correction
(prothrombin time >18s, prothrombin activity <40%, platelet <80×109 /L);
3. Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before
surgery;
4. Severe pulmonary fibrosis and pulmonary hypertension;
5. Patients with poor control of pleural effusion;
6. Patients with serious insufficiency of Liver, kidney, heart, lung, and brain
function;
7. Patients with Severe anemia, dehydration, and severe disturbance of nutrient
metabolism, which cannot be corrected or improved in the short term;
8. Patients with severe systemic infection, high fever (>38.5℃);
9. Pregnant and lactating women and those planning to become pregnant within one year;
10. Participants in clinical trials of any drugs and/or medical devices within 3 months
before enrollment;
11. Any other factors that the investigator considers inappropriate for inclusion or
that may affect the subject's participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Lingxiao Liu
Phone:
+86-18616881019
Email:
w_feihang@163.com
Investigator:
Last name:
Lingxiao Liu, MD
Email:
Principal Investigator
Start date:
July 31, 2024
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06530667
