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A prospective, single-center, randomized, non-inferior study on the safety and efficacy of bronchial navigation devices for pre-operative localization of pulmonary nodules followed by video-assisted thoracoscopic surgery (CHINAVI 001)

A prospective, single-center, randomized, non-inferior study on the safety and efficacy of bronchial navigation devices for pre-operative localization of pulmonary nodules followed by video-assisted thoracoscopic surgery (CHINAVI 001)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078960
Enrollment
Unknown
Registered
2023-12-21
Start date
2023-12-31
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Lung Cancer

Interventions

experimental group:The Infinity Essense? bronchial navigation device guides preoperative positioning staining
control group:The superDimension? magnetic Navigation system guides preoperative positioning staining

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1: Age = 18 years and = 70 years, regardless of gender. 2: Subjects with lung nodules = 2cm in diameter and a distance of = 0.5cm from the pleura, who are planned to undergo VATS (Video-Assisted Thoracic Surgery) sublobar resection. 3: Subjects who have difficulties in direct visualization or tactile localization of the pulmonary nodules and require auxiliary localization. 4: Signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1: Contraindications to bronchoscopy or VATS surgery, such as severe cardiac or pulmonary dysfunction, severe hypertension and arrhythmia, uncorrectable bleeding tendency or severe coagulation disorders (e.g., platelet count < 60 × 10^9/L), uremia, severe pulmonary hypertension, increased intracranial pressure, acute cerebrovascular events, aortic dissection or aneurysm, extreme systemic failure, and other conditions. 2: Subjects with a history of previous thoracic surgery and suspected severe pleural adhesions. 3: Subjects with allergies to fibrin glue, methylene blue, indocyanine green, or other contrast agents, or a history of multiple severe allergies or hereditary allergies. 4: Subjects deemed unsuitable for VATS sublobar resection based on multidisciplinary discussions. 5: Nursing, pregnant, or actively trying to conceive females. 6: Other situations in which the investigator determines that participation in this clinical study is not suitable.

Design outcomes

Primary

MeasureTime frame
Staining location accuracy ;

Secondary

MeasureTime frame
Success rate of positioning;Success rate of resection;Distance from staining point to the nodule;Dispersion rate of staining;Deviation distance of positioning ;Completion time of staining;Changes in lung function;

Countries

China

Contacts

Public ContactLuo Kongjia

Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou City, Guangdong Province, P.R. China

luokj@sysucc.org.cn+86 135 7099 9826

Outcome results

None listed

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