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

NCT04139408 | Completed

• 1 other identifier: BC-HM-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

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).

Conditions

Lung Cancer

Keywords

Pulmonary Nodule; Localization; Marker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Positioning success rate (in terms of marker placement)

  Immediately after VATS

• Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations:

  Immediately after marker placement

• Operation time of Marker placement (in terms of marker placement)

  Immediately after marker placement

• Operation time of marker release through bronchoscopy (in terms of marker placement)

  Immediately after marker placement

• Operation time of exploration and removal of target lesion during VATS (in terms of marker placement)

  Immediately after VATS

Study Arms (1)

Disposable Pulmonary Surgical Marker

EXPERIMENTAL

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

Device: Disposable Pulmonary Surgical Marker

Interventions

Disposable Pulmonary Surgical Marker DEVICE

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

Disposable Pulmonary Surgical Marker

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Broncus Medical Co., Ltd.: lead

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

Yunnan Cancer Hospital

Kunming, China

Location

Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen Center

Shenzhen, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bin Qiu, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: July 22, 2020
• Primary Completion: December 24, 2020
• Study Completion: January 26, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)