Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139408
• Other study ID #: BC-HM-01
• Status: Completed
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: January 26, 2021

Study information

• Verified date: May 2021
• Source: Hangzhou Broncus Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 26, 2021
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules

Intervention

Device:
• Disposable Pulmonary Surgical Marker
The subjects will undergo Marker placement procedure, within 24h before VATS.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Yunnan Cancer Hospital	Kunming
China	Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen Center	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Broncus Medical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations:	The marker conveyor goes through the bronchoscope and reaches the target release position; Marker is successfully released; Fully retract the conveyor; Complete all the above steps and record the success of the operation as "rate".	Immediately after marker placement
Secondary	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
Secondary	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
Secondary	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
Secondary	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