NCT06220526

Brief Summary

This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis, as defined by improved sample quality for pathological diagnosis compared to the conventional Menghini-type needle.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress77%
Aug 2023Feb 2027

Study Start

First participant enrolled

August 18, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

November 27, 2023

Last Update Submit

April 27, 2026

Conditions

Suspected Sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • Rate of adequate tissue sampling from lymph nodes (as determined by pathologists)

    To compare the performance characteristics of endobronchial ultrasound-guided transbronchial needle aspiration with Menghini-type needle and Franseen-type needle

    3 years

Study Arms (2)

Menghini-type needle

OTHER

the standard needle type

Device: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)

Franseen-type needles

ACTIVE COMPARATOR

the active comparator arm

Device: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)

Interventions

endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)DEVICE

Transbronchial biopsy with Menghini-type or Franseen type Needle

Franseen-type needlesMenghini-type needle

Eligibility Criteria

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

You may qualify if:

  • Any adult patient aged 18 years or older with enlarged mediastinal and/or hilar lymph nodes
  • (≥10 mm short-axis diameter on a CT scan), suspected as having sarcoidosis based on clinical
  • history, physical exam, and other investigations, and booked for EBUS-TBNA.

You may not qualify if:

  • Patients that are unable to provide informed consent
  • \- Patients with lymphadenopathy strongly suspected to be secondary to other diseases based on
  • clinical history, physical exam, and/or other investigations (e.g., lung cancer, lymphoma,
  • infection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 1L7, Canada

RECRUITING

Study Officials

  • Kazuhiro Yasufuku

    UHN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy McConnell

CONTACT

416-581-7849judy.mcconnell@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Head. Division of Thoracic Surgery

Study Record Dates

First Submitted

November 27, 2023

First Posted

January 24, 2024

Study Start

August 18, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)