Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722432
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2020-10-16
Brief Title:
Evaluation of Deployment Capability and Accuracy of an Outside the Scope OTS Detachable Catheter System for Ablation of Peripheral Lung Lesions An Ex-Vivo Human Lung Model Study
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Evaluation of Deployment Capability and Accuracy of an Outside the Scope OTS Detachable Catheter System for Ablation of Peripheral Lung Lesions An Ex-Vivo Human Lung Model Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A novel OTS detachable probe system carried outside and along the flexible bronchoscope has been developed Using this novel system the operator can deploy the probe in the target bronchus and lesion and completely detach the scope from the probe
Detailed Description:
Lung ablative therapies have growing interest in the treatment of early-stage primary lung cancer in surgical high-risk patients and as part of multimodal treatment in patients with large lesions or metastatic malignant disease in the lungs Endobronchial ablative strategies allow deliver y of these therapies through a natural orifice and minimally invasive approach potentially improving safety and reducing related morbidity Application and deployment of this system allows the operator to have constant control of the airway preventing life-threatening hemoptysis and other complications We hypothesize that this novel detachable OTS system can be successfully deployed in the peripheral parenchymal target with potential clinical applications in the near future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None