Status:
COMPLETED
Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
Lead Sponsor:
Hangzhou Broncus Medical Co., Ltd.
Conditions:
Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
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 st...
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 rem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2021
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04139408
Start Date
July 22 2020
End Date
January 26 2021
Last Update
May 19 2021
Active Locations (3)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
2
Yunnan Cancer Hospital
Kunming, China
3
Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen Center
Shenzhen, China