Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
During the VATS procedure, some pulmonary nodules are relatively small or far away from the pleura, resulting that they are difficult to be accurately located during the procedure.
The aim of this study is to evaluate the efficacy and safety of using disposable pulmonary surgical markers to localize pulmonary nodules in subjects prior to the resection of pulmonary nodules by video-assisted thoracoscopic surgery (VATS).
It is a prospective, multicenter, single group target value clinical trial. The subjects will undergo VATS within 24h after the placement of the Marker, then the Marker and targeted nodule will be removed during VATS. Subjects will be followed up intraoperatively, immediately after placement procedure to the end of VATS resection, 7 days after placement procedure/before discharge (whichever occurs earlier), and 30 days after Marker placement procedure. Demographic and baseline information of subjects, immediate operation success rate of marker placement, positioning success rate, and adverse events will be collected and recorded in this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disposable Pulmonary Surgical Marker | Experimental | Locate the pulmonary nodules with Disposable Pulmonary Surgical Marker before VATS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disposable Pulmonary Surgical Marker | Device | The subjects will undergo Marker placement procedure, within 24h before VATS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positioning success rate | The proportion of patients who complete VATS resection of target pulmonary nodules/number of patients receiving localization of target pulmonary nodules before operation, expressed as "rate", will be evaluated during and immediately after surgery to evaluate the effectiveness of disposable pulmonary surgical markers in the localization of pulmonary nodules in surgery. | Immediately after VATS |
| Measure | Description | Time Frame |
|---|---|---|
| Positioning success rate (in terms of marker placement) | The proportion of target pulmonary nodules underwent VATS resection/number of pulmonary nodules receiving localization before operation, expressed as "rate". | Immediately after VATS |
| Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations: |
Not provided
Inclusion Criteria:
Age 18-70 years oldï¼›
Pulmonary nodule, which satisfying any of the following Criteria:
Pulmonary wedge resection or Segmental pulmonary resection under VATS is proposed;
Preoperative evaluation shows that placing marker through bronchus is feasibleï¼›
The subject is able to fully understand the requirements of clinical research;
Subject or the legal representative signs the informed consent form.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bin Qiu, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China | ||||
| Yunnan Cancer Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Complete all the above steps and record the success of the operation as "rate". |
| Immediately after marker placement |
| Operation time of Marker placement (in terms of marker placement) | Defined as starting from the time the marker conveyor is inserted into the bronchoscope until it is withdrew from the bronchoscope. | Immediately after marker placement |
| Operation time of marker release through bronchoscopy (in terms of marker placement) | Defined as starting from the time when the bronchoscope is inserted into the airway to the time when the marker conveyor is removed from the bronchoscope. | Immediately after marker placement |
| Operation time of exploration and removal of target lesion during VATS (in terms of marker placement) | Defined as starting lesion location exploration after the completion of preoperative surgical preparation and VATS access ports made, to the time of resection and removal of lung tissue. | Immediately after VATS |
| Safety: AEs (Adverse Events) and SAEs (Serious Adverse Events) occured during the clinical trial | AEs and SAEs occured from marker placement to 30days after the placement procedure. | 30days |
| Kunming |
| China |
| Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen Center | Shenzhen | China |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |