Open Label Trial of Utility of Cryobiopsy in the Multidis... | NCT02563730

Studies
Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease

NCT02563730

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Oct 26, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Interstitial Lung Disease

Interventions

Lung biopsy

Countries

Germany
Italy
Spain
United Kingdom

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

Oct 2016

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

Nov 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Not provided

First Submitted Date

May 2, 2015

First Submission Date that Met QC Criteria

Sep 28, 2015

First Posted Date

Sep 30, 2015Estimated

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

Oct 25, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia

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

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung biopsy	Experimental	assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS	Procedure: Lung biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung biopsy	Procedure	transbronchial lung biopsy. First kryobiopsy, second open biopsy	Lung biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy		two weeks

Secondary Outcomes

Measure	Description	Time Frame
numer of bleeding events		1 day
Rate of pneumothoraxes		1 day
numer of exacerbations after biopsy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IIP suspected on clinical and radiologic grounds

Exclusion Criteria:

Age >80y and <18y
FVC< 55%, DCO<35%
Platelet count <100000/µl
acetylsalicylic acid, clopidogrel or equivalent during the last 5 days
INR > l,3,
elevated PTT (> 40 s)
documented pulmonary hypertension PAPS >50mmHg
HR-CT highly suspicious for sarcoidosis

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruhrlandklinik	Recruiting	Essen		45239	Germany

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided