NCT06056882

Brief Summary

It is planned to use the CLE probe and cryoprobe simultaneously after detection of the round focus. It is planned to include 5 patients with suspected central airway invading lung carcinoma and 15 patients with suspected peripheral lung carcinoma who have an indication for bronchoscopic histologic confirmation.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

September 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

September 20, 2023

Last Update Submit

February 9, 2024

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and feasibility

    Advers events

    during bronchoscopy procedure

Study Arms (1)

Study group

Other: CLE-guided cryobiopsy

Interventions

CLE-guided cryobiopsyOTHER

During bronchoscopy, that is performed for suspicious pulmonary lesions, it is planned to use the CLE probe and cryoprobe simultaneously wafter detection of the round focus.

Study group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with indication for bronchoscopy and biopsy for suspicious pulmonary lesions

You may qualify if:

  • \>18 years
  • Suspicion of lung carcinoma

You may not qualify if:

  • Known allergy to fluorescin
  • Pregnancy and/or lactation
  • No discontinuation of ß-blocker 12 hours before intervention possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Daniela Gompelmann

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Gompelmann

CONTACT

014040047730daniela.gompelmann@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

September 20, 2023

Primary Completion

March 31, 2024

Study Completion

June 30, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)