NCT06744725

Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Multicenter Open-label Randomized Controlled Trial

Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Protocol for a Multicenter Open-label Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We designed and developed a novel dual-function semirigid thoracoscope (UE FET-680; UE Corporation, Zhejiang, China) with a straight channel adapted to flexible and rigid forceps for pleural biopsy. Our preclinical trial has proven that the dual-function semirigid thoracoscope has larger and deeper sampling while retaining the entire thoracic accessibility and flexible bronchoscopic maneuvering habits of the semirigid thoracoscope. We designed this study to directly compare the diagnostic yield, quality of sampling, and safety between the dual-function semirigid thoracoscope and semirigid thoracoscope.

Conditions

• Pleural Diseases

Interventions

Type	Name	Description
DEVICE	Pleural biopsy using dual-function semirigid thoracoscopy	Patients will receive pleural biopsy using dual-function semirigid thoracoscopy.
DEVICE	Pleural biopsy using semirigid thoracoscopy	Patients received pleural biopsy using semirigid thoracoscopy

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-11-30
• Completion: 2026-01-01
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

1 site across 1 country: China