Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules

• Sponsor: University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06056882
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 9.3
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease	Other: CLE-guided cryobiopsy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules
• Actual Study Start Date: Sep 20, 2023
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Safety and feasibility [during bronchoscopy]

   Advers events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria

Sponsors and Collaborators

• University of Vienna

Investigators

• Principal Investigator: Daniela Gompelmann, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniela Gompelmann, Prof. Dr. med., University of Vienna
• ClinicalTrials.gov Identifier: NCT06056882
• Other Study ID Numbers: 1.1
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Pulmonary Nodules

Study Results

No Results Posted as of Sep 28, 2023