Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT04758403
Status:
TERMINATED
Last Update Posted:
2024-11-19
First Post:
2021-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CBCT-Guided Navigational Bronchoscopy For Lung Nodules
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to changes in technology (EMN technology replaced by robotic platform) the study was terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.
Detailed Description:
This clinical trial examines the effectiveness of a treatment comparing it to another known treatment.
The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease.
The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease.
This research study involves a screening period, a procedure and follow up visits.
The names of the study interventions involved in this study are:
* Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB)
* Navigation bronchoscopy alone
Participants will receive the study procedure and will be followed for up to 6 months.
It is expected that about 136 people will take part in this research study.
The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease.
The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease.
This research study involves a screening period, a procedure and follow up visits.
The names of the study interventions involved in this study are:
* Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB)
* Navigation bronchoscopy alone
Participants will receive the study procedure and will be followed for up to 6 months.
It is expected that about 136 people will take part in this research study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: