Clinical trial NCT04139408: Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
Official title: A Prospective, Multicenter, Single Group Clinical Study to Evaluate the Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Pulmonary Nodule
Localization
Marker
Lead sponsor: Hangzhou Broncus Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years old；
* Pulmonary nodule, which satisfying any of the following Criteria:

  * solid nodules with diameter ≤1 cm or solid component ≤1 cm non-purely ground glass, and the distance between the solid component of the nodule and the visceral pleural\>0.5cm;
  * Pure ground glass opacity (pGGO)；
  * Before VATS operation, the doctor judge that the nodule is difficult to locate during the operation.
* Pulmonary wedge resection or Segmental pulmonary resection under VATS is proposed;
* Preoperative evaluation shows that placing marker through bronchus is feasible；
* The subject is able to fully understand the requirements of clinical research;
* Subject or the legal representative signs the informed consent form.

Exclusion Criteria:

* Contraindications for bronchoscopy;
* Systemic factors: sepsis, history of repeated pulmonary infections, and any type of severe infectious disease within one month of screening；
* Severe cardio and pulmonary disease；
* Coagulation dysfunction, with a clear tendency to bleed;
* General anesthesia contraindication;
* Allergic history of nickel-titanium materials;
* Breast-feeding or may be or plan to be pregnant during the trial;
* Participating in clinical trials of other drugs or medical devices;
* Other conditions that Investigator consider the subject to be inappropriate.

Primary outcomes:
measure: Positioning success rate
timeFrame: Immediately after VATS
Secondary outcomes:
measure: Positioning success rate (in terms of marker placement)
timeFrame: Immediately after VATS
measure: Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations:
timeFrame: Immediately after marker placement
measure: Operation time of Marker placement (in terms of marker placement)
timeFrame: Immediately after marker placement
measure: Operation time of marker release through bronchoscopy (in terms of marker placement)
timeFrame: Immediately after marker placement
measure: Operation time of exploration and removal of target lesion during VATS (in terms of marker placement)
timeFrame: Immediately after VATS
measure: Safety: AEs (Adverse Events) and SAEs (Serious Adverse Events) occured during the clinical trial
timeFrame: 30days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Shenzhen
country: China
facility: Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen Center
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Bin Qiu, MD
role: PRINCIPAL_INVESTIGATOR
References: