Skip to content

Efficacy and safety of robotic-assisted bronchoscopy combined with the ICNVA strategy in biopsy of peripheral pulmonary nodules: A prospective, single-center, single-arm study

Efficacy and safety of robotic-assisted bronchoscopy combined with the ICNVA strategy in biopsy of peripheral pulmonary nodules: A prospective, single-center, single-arm study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090784
Enrollment
Unknown
Registered
2024-10-13
Start date
2024-10-14
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

non-small cell lung cancer

Interventions

Robot-Assisted Bronchoscopy (RAB):1) Within acceptable range (blood oxygen saturation > 92%), the patient received preoxygenation with the loweccarina of trachea and the opening of each lung lobe for
8) CT scan was performed again, the distance between the biopsy tool and the target location center was confirmed by the researcher, and the position relationship was recorded. Tool-in-lesion (TIL) wa
Center Strike was defined as the end of the biopsy tool reaching one third of the center of the target nodule on the coronal plane, sagittal plane and horizontal plane
Tool-touch-lesion (TIL) was defined as the biopsy tool tangential to the target nodule, but does not enter the target nodule. If the distance between the end of the biopsy tool and the center of the t
9) Biopsy and ROSE (Rapid On-Site Evaluation) were performed to indicate next steps
10) Postoperative CT scan wa

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 years old, and =75 years old, male or female; 2) Patients with peripheral lung lesions found by chest CT, whose diameter = 6mm and < 3cm, who plan to undergo robotic-assisted bronchoscopic for pulmonary biopsy; 3) The patient voluntarily undergo bronchoscopy and meet the requirements for bronchoscopy; 4) Patients can understand the purpose of the trial, have good compliance with the examination and follow-up, voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with cardiovascular diseases, such as blood pressure instability, myocardial infarction or arrhythmia; 2) Patients with massive hemoptysis within two weeks; 3) Patients with severe pneumothorax and rib fracture; 4) Patients with serious infectious diseases, such as tuberculosis or AIDS; 5) Patients with severe abdominal aortic aneurysm or thoracic aortic aneurysm; 6) Participants who have participated in or are participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days; 7) Those who were not considered suitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Tool-in-lesion rate;

Secondary

MeasureTime frame
Center Strike rate;Tool-touch-lesion rate;Successful diagnosis rate;Lesion detection rate;Bronchopulmonary hemorrhage rate;Pneumothorax rate;CT to Body divergence;Successful operation rate;

Countries

People's Republic of China

Contacts

Public ContactShaohua Dai

The First Affiliated Hospital of Nanchang University

ciccy516615@163.com+86 134 7916 5726

Outcome results

None listed

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