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NCT Number: NCT04139408

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).

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Disposable Pulmonary Surgical Marker

Device

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

Primary outcomes

  1. Positioning success rate

    Time frame: Immediately after VATS

    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 outcomes

  1. Positioning success rate (in terms of marker placement)

    Time frame: Immediately after VATS

    The proportion of target pulmonary nodules underwent VATS resection/number of pulmonary nodules receiving localization before operation, expressed as "rate".

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

    Time frame: Immediately after marker placement

    • 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".

  3. Operation time of Marker placement (in terms of marker placement)

    Time frame: Immediately after marker placement

    Defined as starting from the time the marker conveyor is inserted into the bronchoscope until it is withdrew from the bronchoscope.

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

    Time frame: Immediately after 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.

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

    Time frame: Immediately after VATS

    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.

  6. Safety: AEs (Adverse Events) and SAEs (Serious Adverse Events) occured during the clinical trial

    Time frame: 30days

    AEs and SAEs occured from marker placement to 30days after the placement procedure.

Sponsors and collaborators

Lead sponsor

Hangzhou Broncus Medical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 25, 2019
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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