NCT06744725

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

December 9, 2024

Last Update Submit

December 19, 2024

Conditions

Pleural Diseases

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    The diagnostic yield in this study was defined as the proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established.

    6 Month

Study Arms (2)

Dual-function semirigid thoracoscopy

EXPERIMENTAL

Patients received pleural biopsy using dual-function semirigid thoracoscopy.

Device: Pleural biopsy using dual-function semirigid thoracoscopy

Semirigid thoracoscopy

EXPERIMENTAL

Patients received pleural biopsy using semirigid thoracoscopy

Device: Pleural biopsy using semirigid thoracoscopy

Interventions

Pleural biopsy using dual-function semirigid thoracoscopyDEVICE

Patients will receive pleural biopsy using dual-function semirigid thoracoscopy.

Dual-function semirigid thoracoscopy
Pleural biopsy using semirigid thoracoscopyDEVICE

Patients received pleural biopsy using semirigid thoracoscopy

Semirigid thoracoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Unilateral pleural effusion of unclear etiology after a less invasive diagnosis
  • Fully informed of the purpose and method of the study, agreed to participate in the study, and signed an informed consent form.

You may not qualify if:

  • PaO2/FiO2 \< 300
  • Tendency for uncontrolled bleeding, unstable cardiovascular status, or severe heart failure
  • A complete pleural symphysis, where it is not possible to create a pneumothorax
  • Refractory cough
  • Eastern Cooperative Oncology Group performance status 4
  • Disagreements regarding study participation
  • Participation in other studies within three months without withdrawal or termination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (6)

  • Lee P, Colt HG. Rigid and semirigid pleuroscopy: the future is bright. Respirology. 2005 Sep;10(4):418-25. doi: 10.1111/j.1440-1843.2005.00737.x.

    PMID: 16135163RESULT

  • Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.

    PMID: 23418922RESULT

  • Agarwal R, Aggarwal AN, Gupta D. Diagnostic accuracy and safety of semirigid thoracoscopy in exudative pleural effusions: a meta-analysis. Chest. 2013 Dec;144(6):1857-1867. doi: 10.1378/chest.13-1187.

    PMID: 23928984RESULT

  • Collins TR, Sahn SA. Thoracocentesis. Clinical value, complications, technical problems, and patient experience. Chest. 1987 Jun;91(6):817-22. doi: 10.1378/chest.91.6.817.

    PMID: 3581930RESULT

  • Venekamp LN, Velkeniers B, Noppen M. Does 'idiopathic pleuritis' exist? Natural history of non-specific pleuritis diagnosed after thoracoscopy. Respiration. 2005 Jan-Feb;72(1):74-8. doi: 10.1159/000083404.

    PMID: 15753638RESULT

  • Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available.

    PMID: 26350935RESULT

MeSH Terms

Conditions

Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Gang Hou, MD,PhD

CONTACT

010-84205729hougangcmu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 20, 2024

Study Start

January 1, 2025

Primary Completion

November 30, 2025

Study Completion

January 1, 2026

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)