Single Use Flexible Bronchoscopes in Interventional Pulmo... | NCT06144398

Studies
Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

NCT06144398

Sponsor

Clinical Hospital Centre Zagreb

Status

Completed

Last Update Posted

Aug 6, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Atelectasis
Hemoptysis
Stridor

Interventions

Single Use Bronchoscope
Standard Bronchoscope

Countries

Croatia

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2023Actual

Primary Completion Date

Mar 29, 2024Actual

Completion Date

Mar 29, 2024Actual

First Submitted Date

Nov 13, 2023

First Submission Date that Met QC Criteria

Nov 20, 2023

First Posted Date

Nov 22, 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

Aug 4, 2024

Last Update Posted Date

Aug 6, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Goran Glodić, MD, Principal Investigator, Clinical Hospital Centre ZagrebPrincipal Investigator

Lead Sponsor

Clinical Hospital Centre ZagrebOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Single Use Flexible bronchoscopes have gained popularity in recent years and are becoming technologically more advanced. They are widely accepted and used in everyday practice for simple procedures. The aim of this study is to evaluate single use flexible bronchoscopes in more advanced settings, such as interventional pulmonary procedures.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Use Bronchoscope	Experimental		Device: Single Use Bronchoscope
Standard Bronchoscope	Active Comparator		Device: Standard Bronchoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single Use Bronchoscope	Device	The interventional procedure is performed with a single use bronchoscope.	Single Use Bronchoscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall performance	Overall performance of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)	through study completion, an average of 12 months

Secondary Outcomes

Measure	Description	Time Frame
Functionality, handle and interface	Functionality, handle and interface of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)	through study completion, an average of 12 months
Suction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients requiring an interventional pulmonary procedure during the study period
Signed informed consent

Exclusion Criteria:

Any patient with a contraindication for rigid and/or flexible bronchoscopy
Coagulopathy (PV INR > 1.3)
Thrombocytopenia (<50x10*9 or anemia (Hgb <80 g/L)
DOAC, LMWH or antiplatelet drug therapy
Thrombophilia, history of pulmonary embolism or deep vein thrombosis
Contraindication for endobronchial application of adrenaline
Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
Uncontrolled pulmonary hypertension
Cardiovascular decompensation
Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)
Cervical spine instability

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Centre Zagreb		Zagreb		10000	Croatia

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis
D006469	Hemoptysis
D012135	Respiratory Sounds

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided