NCT02611297

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

May 21, 2015

Last Update Submit

November 19, 2015

Conditions

Lung DiseasesInterstitial Disease

Keywords

CryoprobesCryobiopsyTransbronchial lung biopsy

Outcome Measures

Primary Outcomes (1)

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

    27 months

Secondary Outcomes (1)

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

    27 months

Study Arms (1)

Transbronchial lung biopsy with cryoprobe

OTHER
Procedure: Cryoprobe

Interventions

CryoprobePROCEDURE
Transbronchial lung biopsy with cryoprobe

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Germans Tries i Pujol Hospital

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Virginia Pajares, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia Pajares, MD, PhD

CONTACT

+34935565972vpajares@santpau.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2015

First Posted

November 20, 2015

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-10

Locations

ES(3)