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

A Prospective, Multicenter, Single Group Clinical Study to Evaluate the Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules

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).

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Disposable Pulmonary Surgical Marker

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disposable Pulmonary Surgical Marker; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hangzhou Broncus Medical Co., Ltd.
• Investigators: Principal Investigator: Bin Qiu, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Actual): December 24, 2020
• Study Completion (Actual): January 26, 2021

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pulmonary Nodule; Localization; Marker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: BC-HM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No