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The single-arm clinial trial to evaluate the safety and effectiveness of the localization needle for pulmonary nodules

The single-arm clinial trial to evaluate the safety and effectiveness of the disposable localization needle for pulmonary nodules

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-16009360
Enrollment
Unknown
Registered
2016-10-10
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Pulmonary nodules

Interventions

single-arm clinial trial:Computed Tomography-guided Localization with Needle Localization for Lung nodules

Sponsors

SHANGHAI CHEST HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Male and female aged 18 to 75 years old; (2) pulmonary nodules were diagnosed by thoracic CT (diameter = 1cm, solid nodules or ground glass nodules), and to be undergoing thoracoscopic pulmonary wedge resection or segmentectomy or lobectomy; (3) thoracic CT examination showed no significant enlargement of the hilar or mediastinal lymph nodes; (4) voluntarily participate and sign informed consent form, and can complete the entire trial.

Exclusion criteria

Exclusion criteria: (1) The patients who were not suitable for puncture location before operation, such as pleural effusion, severe damage to the lung tissue, etc.; (2) systemic factors, sepsis, pulmonary infection, any type of serious infection diseases within one month; (3) serious heart, brain, lung, liver, kidney disease, severe hypertension patients; (4) severe coagulation dysfunction; (5) with distant metastasis; (6) patients participated in clinical trials of other drugs or medical devices within 30 days prior to screening; (7) other cases of this clinical trial are not considered appropriate.

Design outcomes

Primary

MeasureTime frame
The rate of Localization success;

Secondary

MeasureTime frame
complication;

Countries

China

Contacts

Public ContactZhao Heng

SHANGHAI CHEST HOSPITAL

h_zhao28@hotmail.com+86 13701865603

Outcome results

None listed

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