Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy o… (NCT07136961) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tool-in-lesion rate
Timeframe: Perioperative/Periprocedural
Trial details
NCT IDNCT07136961
SponsorThe First Affiliated Hospital of Nanchang University
. 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.