Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules

NCT06530667 | Not Yet Recruiting

• 1 other identifier: ZS-IR-110R
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules

Conditions

Lung Neoplasm Malignant; Secondary Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after ablation

Secondary Outcomes (4)

• Nodule ablation time

  Immediately after ablation

• Complete ablation rate

  3 months after ablation

• Nodule recurrence rate

  6 months after ablation

• Adverse events

  Up to 6 months

Study Arms (1)

treatment group

EXPERIMENTAL

Patients treated by broadband collaborative pulse ablation

Device: broadband collaborative pulse ablation

Interventions

broadband collaborative pulse ablation DEVICE

Via CT guided, patients with malignant pulmonary nodules would be treated by broadband collaborative pulse ablation

treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lingxiao Liu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingxiao Liu

CONTACT

+86-18616881019; liulingxiao2022@163.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: July 22, 2024
• First Posted: July 31, 2024
• Study Start: July 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)