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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Disposable Pulmonary Surgical Marker
Sponsored by
Hangzhou Broncus Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring Pulmonary Nodule, Localization, Marker

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital Chinese Academy of Medical Sciences
  • Yunnan Cancer Hospital
  • Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Disposable Pulmonary Surgical Marker

Arm Description

Locate the pulmonary nodules with Disposable Pulmonary Surgical Marker before VATS.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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".
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.
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.
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.
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.

Full Information

First Posted
October 23, 2019
Last Updated
May 17, 2021
Sponsor
Hangzhou Broncus Medical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04139408
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
January 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Broncus Medical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Pulmonary Nodule, Localization, Marker

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Disposable Pulmonary Surgical Marker
Arm Type
Experimental
Arm Description
Locate the pulmonary nodules with Disposable Pulmonary Surgical Marker before VATS.
Intervention Type
Device
Intervention Name(s)
Disposable Pulmonary Surgical Marker
Intervention Description
The subjects will undergo Marker placement procedure, within 24h before VATS.
Primary Outcome Measure Information:
Title
Positioning success rate
Description
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
Secondary Outcome Measure Information:
Title
Positioning success rate (in terms of marker placement)
Description
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
Title
Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations:
Description
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".
Time Frame
Immediately after marker placement
Title
Operation time of Marker placement (in terms of marker placement)
Description
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
Title
Operation time of marker release through bronchoscopy (in terms of marker placement)
Description
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
Title
Operation time of exploration and removal of target lesion during VATS (in terms of marker placement)
Description
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
Title
Safety: AEs (Adverse Events) and SAEs (Serious Adverse Events) occured during the clinical trial
Description
AEs and SAEs occured from marker placement to 30days after the placement procedure.
Time Frame
30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Qiu, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Facility Name
Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen Center
City
Shenzhen
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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