NCT07218042

Brief Summary

Currently, the EBUS bronchoscopy procedure uses either one or two needles to perform the biopsy of the lymph node based on physician preference. We want to determine the optimal number of needles to use for future EBUS bronchoscopy procedures like the one you are scheduled to have for your care and investigate the economic and environmental impact and time involved in using one versus two needles.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not 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 Start

First participant enrolled

February 2, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.5 years

First QC Date

October 15, 2025

Last Update Submit

October 15, 2025

Conditions

Mediastinal and Hilar Lymphadenopathy

Keywords

BronchoscopyEBUS

Outcome Measures

Primary Outcomes (1)

  • Time Under Anesthesia

    During bronchoscopy procedure

Study Arms (2)

One EBUS Needle

ACTIVE COMPARATOR

Patients underwent a standard of care EBUS with one needle utilized in the procedure.

Diagnostic Test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.

Two EBUS Needle

EXPERIMENTAL

Patients underwent standard of care EBUS with two needles used.

Diagnostic Test: We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.

Interventions

We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.DIAGNOSTIC_TEST

We randomized patients to the two arms above; there was no specific intervention performed other than randomizing patients to one or two needles.

One EBUS NeedleTwo EBUS Needle

Eligibility Criteria

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

You may qualify if:

  • Undergoing a bronchoscopy with lymph node sampling

You may not qualify if:

  • Unable to get a bronchoscopy procedure for various reasons
  • Other criteria per protocol uploaded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Davis

Sacramento, California, 95817, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Study Design

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

Study Record Dates

First Submitted

October 15, 2025

First Posted

October 20, 2025

Study Start

February 2, 2024

Primary Completion

August 1, 2025

Study Completion

December 31, 2025

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations

US(3)