Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Multicenter Open-label Randomized Controlled Trial
NCT06744725 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334
Last updated 2024-12-20
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
- 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
Sponsors & Collaborators
-
China-Japan Friendship Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-01
- Primary Completion
- 2025-11-30
- Completion
- 2026-01-01
Countries
- China
Study Locations
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