A Prospective, Single-center, Non-inferiority Clinical Trial Study Evaluating the Effectiveness and Safety of Bronchoscopic Navigation Robot (bronchial Navigation Positioning Device) Guided Dye Marking-assisted Thoracoscopic Pulmonary Nodule Resection

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

With the widespread use of low-dose spiral CT screening for the lungs, an increasing number of small nodules are being detected, and surgical resection is the preferred method for clinical intervention of pulmonary nodules. Staining localization can assist surgeons in accurately locating pulmonary nodules during surgery, achieving complete resection of the nodules while minimizing the resection area, thereby optimizing surgical outcomes. The study will include individuals with pulmonary nodules detected by CT scans who require color localization assistance for thoracoscopic pulmonary nodule resection, randomly divided into two groups: one group will receive bronchoscopic navigation-assisted staining localization, while the other group will receive staining localization guided by an electromagnetic navigation system. The primary outcome is to evaluate the success rate of staining localization between the two groups. This study aims to assess, through a prospective, single-center, randomized controlled clinical trial, whether the success rate of staining localization guided by bronchoscopic navigation robots (experimental group) is not lower than that of staining localization guided by the electromagnetic navigation system (control group), while potentially offering advantages such as a shorter learning curve, ease of operation, and reduced surgical time. This will provide a new efficient and safe method for the localization of pulmonary nodules clinically, greatly supporting accurate treatment of pulmonary nodules.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Aged 18-80 years, regardless of gender;

• Peripheral pulmonary nodules, planned for single lesion non-anatomical sublobar resection via thoracoscopic assistance after preoperative discussion;

• Preoperative assessment indicates that the pulmonary nodules cannot be localized through visual inspection or palpation;

• Patients are able to understand the purpose of the trial, have good compliance with examinations and follow-ups, and voluntarily participate in the clinical trial by signing an informed consent form.

Locations
Other Locations
China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Hecheng Li
lihecheng2000@hotmail.com
021-021-64370045
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Treatment group
Preoperative CT data creates a 3D image of the lung anatomy to plan the navigation path. The surgeon controls the robotic arm in real-time to reach staining marker points for pulmonary nodule localization. After placing the staining catheter in the working channel, 1 ml of indocyanine green is injected at the site. Then the patient is positioned laterally for video-assisted thoracoscopic surgery for nodule resection, initially focusing on sub-lobar resection. More extensive resection is determined based on intraoperative frozen section results.
Sham_comparator: Control group
Based on preoperative CT data, a three-dimensional image of the virtual bronchi is created to plan the navigation path, and manual registration is completed by selecting registration points using a conventional bronchoscope. After registration, the target position is reached under the guidance of the magnetic navigation positioning system, and when the positioning sensor indicates that it has arrived at the staining marker point, a staining catheter is inserted through the working channel to inject 1 ml of indocyanine green at the marker site, followed by thoracoscopic resection of the pulmonary nodule.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov