Interest of Procore Needle® for Diagnosis of Lung Cancer | NCT02931461

Studies
Interest of Procore Needle® for Diagnosis of Lung Cancer

NCT02931461

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Jun 2, 2020Actual

Enrollment

49Estimated

Phase

Not Applicable

Conditions

Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore

Interventions

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 27, 2016Actual

Primary Completion Date

Jul 16, 2018Actual

Completion Date

Jul 16, 2018Actual

First Submitted Date

Sep 7, 2016

First Submission Date that Met QC Criteria

Oct 10, 2016

First Posted Date

Oct 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2020

Last Update Posted Date

Jun 2, 2020Actual

Description Module

Brief Summary

The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
needle Procore ®	Experimental		Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
needle Cook®	Active Comparator		Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration	Procedure		needle Cook® needle Procore ®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of histological diagnoses for each needle		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mediastinal lymphadenopathy >10 millimeters
lung cancer suspected

Exclusion Criteria:

coagulopathy contraindication for midazolam contraindication for bronchoscopy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided