Cryoprobe Transbronchial Lung Biospy in Patients With Mec... | NCT02611297

Studies
Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

NCT02611297

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Unknown status

Last Update Posted

Nov 20, 2015Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Lung Diseases
Interstitial Disease

Interventions

Cryoprobe

Countries

Spain

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 2015

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 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

May 21, 2015

First Submission Date that Met QC Criteria

Nov 19, 2015

First Posted Date

Nov 20, 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

Nov 19, 2015

Last Update Posted Date

Nov 20, 2015Estimated

Name	Class
Hospital Clinic of Barcelona	OTHER
Germans Trias i Pujol Hospital	OTHER

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

The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.

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

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transbronchial lung biopsy with cryoprobe	Other		Procedure: Cryoprobe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cryoprobe	Procedure		Transbronchial lung biopsy with cryoprobe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe		27 months

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes		27 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18 years old
Patients with mechanical ventilation.
Patients with diffuse lung disease of unknown etiology.
Need for confirming/excluding a diagnosis, with therapeutical and prognosis implications.
Inform consent signed by family.

Exclusion Criteria:

Use of anticoagulant therapy or presence of a coagulation disorder (abnormal platelets counts, international normalized ratio > 1.5).
Comorbidities that could increase the risk of the TBLB.
Bullous emphysema.
Hemoptysis, pneumothorax.
Severe respiratory insufficiency requiring PEEP >12 cm H2O

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Virginia Pajares, MD, PhD	Contact	+34935565972		vpajares@santpau.cat

Overall Officials

Name	Affiliation	Role
Virginia Pajares, MD, PhD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Germans Tries i Pujol Hospital	Recruiting	Badalona	Barcelona	08916	Spain

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided