NCT06548451Completed
Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 270 (actual)
- First submitted
- 7 Aug 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06548451
What you commit to
- Study type: Interventional
- Participants enrolled: 270
- From 15 Aug 2024 to the primary completion date, 30 Sept 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with chronic pain issues or those who have been taking pain medications for an extended period.
Other illness
- Patients have uncontrollable mental illness and cannot make subjective assessment.
Other
- More than two lung nodules need to be removed at the same time.
- The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
Who the study is looking for
- Age between 18 and 80 years inclusive;
- No distant metastasis in preoperative clinical assessment;
- The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;
- Target lung nodule diameter is no more than 2 cm;
- The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;
- Non-pleural surface nodules;
- Preoperative ECOG performance status score of 0/1;
- Voluntarily participating in this study and signing an informed consent form.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the people's second hospital Hefei Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jiangyin Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Jiangyin | China | Unknown status |
| Jining No. 1 People's Hospital. Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Donghai County People's Hospital Coordinator of this site? Confirm its status | Lianyungang | China | Unknown status |
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| the First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijia Zhuang | China | Unknown status |
| Zhangjiagang Hospital of Traditional Chinese Medicine, Coordinator of this site? Confirm its status | Zhangjiagang | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.