Transbronchial Needle Forceps for Endobronchial Ultrasound | NCT01145924

Studies
Transbronchial Needle Forceps for Endobronchial Ultrasound

NCT01145924

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Jun 17, 2010Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Lung Cancer
Lymph Nodes

Interventions

EBUS TBNF

Countries

Germany

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Aug 2010Estimated

Completion Date

Aug 2010Estimated

First Submitted Date

Jun 7, 2010

First Submission Date that Met QC Criteria

Jun 16, 2010

First Posted Date

Jun 17, 2010Estimated

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

Jun 16, 2010

Last Update Posted Date

Jun 17, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

Detailed Description

Patients with enlarged mediastinal lymph nodes must be staged. The EBUS TBNA technique is an established technique. Unfortunately the size of the needle is limited to 21 gauge. With tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EBUS TBNF	Active Comparator	single arm trial, patients with enlarged mediastinal nodes will be examine	Procedure: EBUS TBNF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EBUS TBNF	Procedure	Transbronchial needle forceps will be use with the EBUS TBNA scope	EBUS TBNF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with a positive biopsy result		2 days after intervention

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		3 weeks after

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

enlarged mediastinal lymph nodes

Exclusion Criteria:

comorbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Felix JF Herth, PhD, MD	Contact	+49 6221 396	1200	Felix.Herth@thoraxklinik-heidelberg.de

Overall Officials

Name	Affiliation	Role
Hendrik Dienemann, PhD, MD	Heidelberg University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thoraxklinik	Recruiting	Heidelberg		69126	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21700609	Derived	Herth FJ, Schuler H, Gompelmann D, Kahn N, Gasparini S, Ernst A, Schuhmann M, Eberhardt R. Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study. Eur Respir J. 2012 Feb;39(2):373-7. doi: 10.1183/09031936.00033311. Epub 2011 Jun 23.

Type	Date	Date Unknown
Release	Sep 22, 2011
Reset	Oct 31, 2011

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms