NCT05311345

Brief Summary

A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Status
completed

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 6, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
2 years until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

April 17, 2020

Last Update Submit

March 27, 2022

Conditions

Interstitial Lung Disease

Keywords

Cryobiopsy

Outcome Measures

Primary Outcomes (4)

  • Pneumothorax

    Pneumothorax, hemorrhage, acute exacerbation and death

    2 weeks

  • Hemorrhage

    Hemorrhage during the procedure

    3 days

  • Acute exacerbation

    Acute exacerbation after the procedure

    100 days

  • Mortality

    Mortality after the procedure

    100 days

Secondary Outcomes (1)

  • Diagnostic yield

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients under investigation for Interstitial lung diseases that were having cryobiopsies performed.

You may qualify if:

  • \>18years of age
  • suspected of Interstitial lung Disease
  • cryobiopsies performed.

You may not qualify if:

  • FVC below 50% of predicted
  • DLCO below 35%
  • Body Mass Index (BMI) above 35
  • pulmonary hypertension with a tricuspidal gradient above 40 mmHg
  • other cardiac or other comorbidities that would increase the risk of complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, principal investigator

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 5, 2022

Study Start

November 6, 2015

Primary Completion

September 10, 2019

Study Completion

April 1, 2020

Last Updated

April 5, 2022

Record last verified: 2022-03