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A prospective, multicenter, randomized, parallel controlled, non inferiority clinical trial for minimally invasive cryotherapy system (Combined Cryosurgery System)

A prospective, multicenter, randomized, parallel controlled, non inferiority clinical trial for minimally invasive cryotherapy system (Combined Cryosurgery System)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034353
Enrollment
Unknown
Registered
2020-07-03
Start date
2014-01-01
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Solid tumor other then cavity tumor

Interventions

Sponsors

Dongfang Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: All selected subjects must meet the following relevant conditions: 1. the patient or legal representative voluntarily participate, and signing the patient's informed consent form; 2. patients aged 18-80 years of age (subject to the date of signing the informed consent form); 3. patients with primary or secondary solid tumors (III-IV stage of lung cancer, hepatic carcinoma, renal cancer) who have been clinically diagnosed, and the lesions can be measured(The maximum diameter is 2-5 cm), requiring minimally invasive surgery; 4. no similar minimally invasive surgery was performed within 1 month; 5. those who have not undergone radiotherapy or chemotherapy within 2 month; 6. expected lifetime more than three months; 7. people who can correctly describe and are willing to participate in follow-up treatment; 8. patients who are considered suitable for this clinical study by the researcher.

Exclusion criteria

Exclusion criteria: If find one of the following relative conditions, the subject will not be able to participate in the clinical study: 1. There are traumatic injuries in the chest and abdomen that can cause surgical infection; 2. patients with severe infections and severe heart and brain diseases; have a history of immunodeficiency, including HIV testing positive (enzyme-linked immunosorbent assay and Western blotting); 3. Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder and multiple pulmonary bullae; 4. Patients with abnormal indexes in routine examination (blood routine, urine routine, liver and kidney function, ECG, biochemical test); 5. Patients with severe coagulation disorders; 6. Patients with recurrence or metastasis within 3 months after treatment with other methods; 7. pregnant or lactating women; 8.patient was taking part in other clinical trail; 9. patient did not signe the informed consent form; 10. patients who are considered unsuitable for this clinical study by the researcher.

Design outcomes

Primary

MeasureTime frame
the iceball coverage efficiency;the overall of the response rate ;

Secondary

MeasureTime frame
Evaluation of treatment tolerance;The score of life quality;

Countries

China

Contacts

Public ContactHu Kaiwen

Dongfang Hpspital Affiliated to Beijing University of Traditional Chinese Medicine

yf@hygeamed.com+86 13911650713

Outcome results

None listed

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