Active — Not RecruitingNot Applicable

Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules

China30 participantsStarted 2024-12-28

Plain-language summary

To assess the efficacy and safety of robotic-assisted bronchoscopy system (bronchial navigation and positioning device) combined with ICNVA strategy for peripheral pulmonary nodule biopsy through a prospective, single-center, single-arm study.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years old, and ≤75 years old, male or female;
✓. Patients with peripheral lung lesions found by chest CT, whose diameter ≥ 6mm and \< 3cm, who plan to undergo robotic-assisted bronchoscopic for pulmonary biopsy;
✓. The patient voluntarily undergo bronchoscopy and meet the requirements for bronchoscopy;
✓. 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

✕. Patients with cardiovascular diseases, such as blood pressure instability, myocardial infarction or arrhythmia;
✕. Patients with massive hemoptysis within two weeks;
✕. Patients with severe pneumothorax and rib fracture;
✕. Patients with serious infectious diseases, such as tuberculosis or AIDS;
✕. Patients with severe abdominal aortic aneurysm or thoracic aortic aneurysm;
✕. 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;
✕. Those who were not considered suitable for inclusion by the researchers.

What they're measuring

Tool-in-lesion rate

Timeframe: Perioperative/Periprocedural

Trial details

NCT IDNCT07136961

SponsorThe First Affiliated Hospital of Nanchang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-08

View on ClinicalTrials.gov More Lung Nodules trials