NCT04139408

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Hangzhou Broncus Medical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Disposable Pulmonary Surgical Marker	The subjects will undergo Marker placement procedure, within 24h before VATS.

Timeline

• Start date: 2020-07-22
• Primary completion: 2020-12-24
• Completion: 2021-01-26
• First posted: 2019-10-25
• Last updated: 2021-05-19

Locations

3 sites across 1 country: China