An interventional study of Disposable Pulmonary Surgical Marker in Lung Cancer, sponsored by Hangzhou Broncus Medical Co., Ltd.. Completed at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-19.
Sponsored by Hangzhou Broncus Medical Co., Ltd. · Not applicable, Interventional, and Other
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.
Pulmonary nodule, which satisfying any of the following Criteria:
Exclusion Criteria:
Locate the pulmonary nodules with Disposable Pulmonary Surgical Marker before VATS.
Device: Disposable Pulmonary Surgical Marker
The subjects will undergo Marker placement procedure, within 24h before VATS.
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.
Time frame: Immediately after VATS
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".
Time frame: Immediately after VATS
Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations:
1. The marker conveyor goes through the bronchoscope and reaches the target release position 2. Marker is successfully released 3. Fully retract the conveyor Complete all the above steps and record the success of the operation as "rate".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hangzhou Broncus Medical Co., Ltd.