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A prospective, multicenter, randomized, three-arm, parallel-controlled clinical study of the efficacy and safety of an electrocooled ablation system for the treatment of lung tumors

A prospective, multicenter, randomized, three-arm, parallel-controlled clinical study of the efficacy and safety of an electrocooled ablation system for the treatment of lung tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068596
Enrollment
Unknown
Registered
2023-02-24
Start date
2023-02-23
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung tumors (primary lung cancer and metastatic lung cancer)

Interventions

Test group:Standard treatment plus electrocooling ablation system
Standard treatment group:Standard treatment of lung tumors (clinical guidelines for the treatment of primary lung cancer and metastatic lung cancer)
Control group:Standard treatment plus cryosurgery system

Sponsors

Dongfang Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 to 85 years old (including 18 and 85 years old), both sexes; 2) Patients with clearly diagnosed primary lung cancer or metastatic lung cancer, with the number of unilateral lung lesions = 3, target lesions measurable, 1 cm < target lesion < 6 cm, requiring ablative surgical treatment; 3) Those who cannot tolerate surgical resection or refuse it; 4) ECOG physical status score 0~2; 5) Voluntary participation with the free will of the subject or legal representative, and signed informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those with small cell lung cancer; 2) Those with tumors combined with infectious or radiological inflammation and large ipsilateral pleural effusions; 3) Those with impaired pulmonary function due to severe lung disease with 150 mmHg or diastolic blood pressure (DBP) > 95 mmHg; 9) Those with uncontrollable arrhythmias, with episodes of myocardial infarction within six months; 10) Expected survival < 3 months; 11) Pregnant and lactating women and those who plan to become pregnant within one year; 12) Those with mental illness, impaired consciousness and inability to cooperate with treatment; 13) Those who participate in other clinical trials within one month; 14) Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
Efficiency at 3 months after tumor ablation;

Secondary

MeasureTime frame
Efficiency at 1,3, 6 and 12 months after ablation;Immediate efficacy after ablation;Changes in CT values after ablation;Disease control rates at 1, 3, 6, and 12 months after ablation;Local recurrence rates at 1, 3, 6, and 12 months after ablation;Serum tumor marker test: CEA, CYFRA21-1, SCC;ECOG Rating;Overall survival rate at 1 year after surgery;

Countries

China

Contacts

Public Contactquanwang li

Dongfang Hospital Beijing University of Chinese Medicine

quanwangli@126.com13691371560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026