search
Back to results

Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

Primary Purpose

Lung Diseases, Interstitial Disease

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cryoprobe
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases focused on measuring Cryoprobes, Cryobiopsy, Transbronchial lung biopsy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Germans Tries i Pujol HospitalRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Clinic de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Transbronchial lung biopsy with cryoprobe

Arm Description

Outcomes

Primary Outcome Measures

Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe

Secondary Outcome Measures

Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes

Full Information

First Posted
May 21, 2015
Last Updated
November 19, 2015
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Hospital Clinic of Barcelona, Germans Trias i Pujol Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02611297
Brief Title
Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Hospital Clinic of Barcelona, Germans Trias i Pujol Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial Disease
Keywords
Cryoprobes, Cryobiopsy, Transbronchial lung biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transbronchial lung biopsy with cryoprobe
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Cryoprobe
Primary Outcome Measure Information:
Title
Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe
Time Frame
27 months
Secondary Outcome Measure Information:
Title
Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes
Time Frame
27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Virginia Pajares, MD, PhD
Phone
+34935565972
Email
vpajares@santpau.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Pajares, MD, PhD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Tries i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Andreo, MD, PhD
Email
fandreo@separ.es
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Pajares, MD, PhD
Phone
+34935565792
Email
vpajares@santpau.cat
First Name & Middle Initial & Last Name & Degree
Alfons Torrego, M.D.
First Name & Middle Initial & Last Name & Degree
Ana Muñoz, M.D.
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Agustí, MD, PhD
Phone
+3493 227 54 00
Email
CAGUSTI@clinic.ub.es

12. IPD Sharing Statement

Learn more about this trial

Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

We'll reach out to this number within 24 hrs