NCT02563730

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

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
4 countries

6 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, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

May 2, 2015

Last Update Submit

October 25, 2016

Conditions

Interstitial Lung Disease

Keywords

Cryobiopsylung biopsyinterstitial lung disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy

    two weeks

Secondary Outcomes (10)

  • numer of bleeding events

    1 day

  • Rate of pneumothoraxes

    1 day

  • numer of exacerbations after biopsy

    6 weeks

  • Contribution of BAL and cryobiopsy to diagnosis

    2 weeks

  • Size of specimen

    2 weeks

  • +5 more secondary outcomes

Study Arms (1)

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

Lung biopsyPROCEDURE

transbronchial lung biopsy. First kryobiopsy, second open biopsy

Lung biopsy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IIP suspected on clinical and radiologic grounds

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ruhrlandklinik

Essen, 45239, Germany

RECRUITING

Thoraxklinik

Heidelberg, 69126, Germany

RECRUITING

University Hospital Tuebingen

Tübingen, Germany

RECRUITING

Ospedale G.B. Morgagni

Forlì, 47100, Italy

RECRUITING

Respiratory Department Hospital of Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Royal Brompton Hospital

London, SW3 6LR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 2, 2015

First Posted

September 30, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

IT(1)GB(1)DE(3)ES(1)