Lung Neoplasm MalignantNCT06530667
Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules
A study testing broadband collaborative pulse ablation in people with Lung Neoplasm Malignant and Secondary Lung Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Neoplasm Malignant, Secondary Lung Cancer
- What is being tested?
- broadband collaborative pulse ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: between 18 and 70 years old with no gender limitation;
- 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;
- Surgery is not available or the patient refuses surgical treatment;
- Nodules' Maximum diameter≤2cm;
- ECOG score≤2;
- Patients understood the trial procedure and voluntarily signed informed consent.
Who cannot join
- An electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body;
- Coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time >18s, prothrombin activity <40%, platelet <80×109 /L);
- Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before surgery;
- Severe pulmonary fibrosis and pulmonary hypertension;
- Patients with poor control of pleural effusion;
- Patients with serious insufficiency of Liver, kidney, heart, lung, and brain function;
Show all 11Show fewer
- Patients with Severe anemia, dehydration, and severe disturbance of nutrient metabolism, which cannot be corrected or improved in the short term;
- Patients with severe systemic infection, high fever (>38.5℃);
- Pregnant and lactating women and those planning to become pregnant within one year;
- Participants in clinical trials of any drugs and/or medical devices within 3 months before enrollment;
- Any other factors that the investigator considers inappropriate for inclusion or that may affect the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Lingxiao Liu, +86-18616881019, w_feihang@163.com
Lingxiao Liu, MD
About this study
Official title: A Prospective Clinic Study to Evaluate the Effectiveness Safety and Feasibility of the Broadband Collaborative Pulse Ablation Instrument in Treating Malignant Pulmonary Nodules
Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules
Read the 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.
- Conditions
- Lung Neoplasm Malignant, Secondary Lung Cancer
- Being tested
- broadband collaborative pulse ablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
broadband collaborative pulse ablationDevice
Via CT guided, patients with malignant pulmonary nodules would be treated by broadband collaborative pulse ablation
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Patients treated by broadband collaborative pulse ablation Receives: Device: broadband collaborative pulse ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ablation success rate
Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated.
Measured: 1 month after ablation
Secondary outcomes (4)
Nodule ablation time
The time taken for nodule ablation is recorded according to the time displayed by the ablation instrument
Measured: Immediately after ablation
Complete ablation rate
Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated
Measured: 3 months after ablation
Nodule recurrence rate
Ablation recurrence rate = (numbers of nodule recurrence) / (numbers of nodule be ablated). Contrast-enhanced CT showed the presence of an enhancement foci within the area of nodule ablation, and the nodule was considered to be recurrence.
Measured: 6 months after ablation
Adverse events
Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start31 Jul 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lingxiao Liu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530667
- Sponsor's protocol ID
- ZS-IR-110R
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinic Study to Evaluate the Effectiveness Safety and Feasibility of the Broadband Collaborative Pulse Ablation Instrument in Treating Malignant Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT06530667
- Acronym / sponsor ID
- ZS-IR-110R
- Conditions
- Lung Neoplasm Malignant, Secondary Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: broadband collaborative pulse ablationPatients treated by broadband collaborative pulse ablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: between 18 and 70 years old with no gender limitation;
- 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;
- Surgery is not available or the patient refuses surgical treatment;
- Nodules' Maximum diameter≤2cm;
- ECOG score≤2;
Key exclusion criteria (11 listed)
- An electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body;
- Coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time >18s, prothrombin activity <40%, platelet <80×109 /L);
- Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before surgery;
- Severe pulmonary fibrosis and pulmonary hypertension;
- Patients with poor control of pleural effusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| broadband collaborative pulse ablationVia CT guided, patients with malignant pulmonary nodules would be treated by broadband collaborative pulse ablation | Device | treatment group |
Primary outcome
Ablation success rate
Time frame: 1 month after ablation
Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated.
4 secondary outcomes
Nodule ablation time
Time frame: Immediately after ablation
Complete ablation rate
Time frame: 3 months after ablation
Nodule recurrence rate
Time frame: 6 months after ablation
Adverse events
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Lung Neoplasm Malignant
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
Enrolling by invitationObservational study
Harvesting Cells for Experimental Cancer Treatments
Melanoma, Gastrointestinal Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 2
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
Advanced Lung Neuroendocrine Tumor, Functioning Lung Neuroendocrine Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingxiao Liu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing broadband collaborative pulse ablation in people with Lung Neoplasm Malignant and Secondary Lung Cancer, run by Shanghai Zhongshan Hospital 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingxiao Liu (+86-18616881019, liulingxiao2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ablation success rate (time frame: 1 month after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2024.