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RECRUITING
NCT06515015
NA

Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax

Sponsor: Hangzhou Broncus Medical Co., Ltd.

View on ClinicalTrials.gov

Summary

Study Objective: To evaluate the feasibility and safety of the disposable endobronchial silicon spigots for treating refractory pneumothorax and to preliminarily assess its efficacy, providing domestic experience for the development and clinical application of bronchial occlusion. Study Population: Patients intended to receive selective bronchial occlusion technology for the treatment of refractory pneumothorax. Sample Size: This study is a preliminary exploration of the application value of the disposable endobronchial silicon spigots occlusion technology in refractory pneumothorax. The sample size has not been strictly calculated, and it is expected to include 10 patients. Study Design: This study is an exploratory, single-group, single-center clinical study.

Official title: Exploratory, Single-Group, Single-Center Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-08

Completion Date

2026-08

Last Updated

2024-08-15

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Endobronchial Silicon Spigots

The single-use endobronchial silicon spigot is injection-molded from implant-grade silicone and has a solid conical body. The endobronchial silicon spigot is used for the temporary occlusion of the target bronchus. It is delivered to the target bronchus through a bronchoscope using biopsy forceps, and the position of the blocker is adjusted to occlude the responsible bronchus leading to the pleural air leakage.

Locations (1)

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China