Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules

February 9, 2024 updated by: Daniela Gompelmann, University of Vienna

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with indication for bronchoscopy and biopsy for suspicious pulmonary lesions

Description

Inclusion Criteria:

  • >18 years
  • Suspicion of lung carcinoma

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Other: CLE-guided cryobiopsy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and feasibility
Time Frame: during bronchoscopy procedure
Advers events
during bronchoscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Investigators

  • Principal Investigator: Daniela Gompelmann, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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