Simultaneous CLE Guided Crybiopsy in Patients With Pulmon... | NCT06056882

Studies
Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules

NCT06056882

Sponsor

University of Vienna

Status

Unknown status

Last Update Posted

Feb 12, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Pulmonary Disease

Interventions

CLE-guided cryobiopsy

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2023Actual

Primary Completion Date

Mar 31, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Sep 20, 2023

First Submission Date that Met QC Criteria

Sep 20, 2023

First Posted Date

Sep 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2024

Last Update Posted Date

Feb 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group			Other: CLE-guided cryobiopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CLE-guided cryobiopsy	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with indication for bronchoscopy and biopsy for suspicious pulmonary lesions

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniela Gompelmann	Contact	014040047730		daniela.gompelmann@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Daniela Gompelmann	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna			Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided