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

NCT ID: NCT04139408

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2021-01-26

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Disposable Pulmonary Surgical Marker

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

Group Type: EXPERIMENTAL

Disposable Pulmonary Surgical Marker

Intervention Type: DEVICE

The subjects will undergo Marker placement procedure, within 24h before VATS.

Interventions

Disposable Pulmonary Surgical Marker

The subjects will undergo Marker placement procedure, within 24h before VATS.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Broncus Medical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bin Qiu, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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, , China

Countries

China

Other Identifiers

BC-HM-01

Identifier Type: -

Identifier Source: org_study_id