NCT03656003

Brief Summary

This study evaluates the yield and safety of two different needles for performing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) in patients with sarcoidosis. The two needles that will be compared will be the 22-gauge ProCore needle and the conventional 22-gauge EBUS-TBNA needle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

August 22, 2018

Last Update Submit

February 22, 2021

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with sarcoidosis diagnosed by EBUS-TBNA (Diagnostic yield)

    The diagnostic yield is defined as the proportion of patients with a final diagnosis of sarcoidosis diagnosed by EBUS-TBNA

    6 months

Secondary Outcomes (2)

  • Number of patients with adequate EBUS-TBNA aspirate on cytology

    2 weeks

  • Incidence of adverse events related to EBUS-TBNA procedure in the two groups

    1 week

Study Arms (2)

Procore needle

EXPERIMENTAL

EchoTip ProCore needle (Cook Medical Inc., Bloomington, Ind., USA)

Device: Procore biopsy needle

Conventional needle

ACTIVE COMPARATOR

Conventional 22-gauge EBUS-TBNA needle (Vizishot, Olympus, Japan)

Device: Conventional biopsy needle

Interventions

Procore biopsy needleDEVICE

EBUS-TBNA with the EchoTip ProCore needle (Cook Medical Inc., Bloomington, Ind., USA)

Procore needle
Conventional biopsy needleDEVICE

EBUS-TBNA with the conventional 22-gauge EBUS-TBNA needle (Vizishot, Olympus, Japan)

Conventional needle

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age group of 18 to 75 years
  • Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
  • Enlarged hilar and mediastinal lymph nodes \>10 mm (any axis) on computed tomography of the chest
  • Ability to provide informed consent to participate in the study

You may not qualify if:

  • Hypoxemia (SpO2 \<92% on FiO2 of 0.3)
  • Treatment with systemic glucocorticoids for \>2 weeks in the preceding three months
  • Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
  • Failure to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

Location

Related Publications (1)

  • Dhooria S, Sehgal IS, Prasad KT, Muthu V, Gupta N, Bal A, Ram B, Aggarwal AN, Agarwal R. Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis. Expert Rev Med Devices. 2021 Feb;18(2):211-216. doi: 10.1080/17434440.2021.1876560. Epub 2021 Jan 22.

    PMID: 33435733DERIVED

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Ashutosh N Aggarwal

    Professor & Head

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 22, 2018

First Posted

September 4, 2018

Study Start

August 1, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

IN(1)