Viewing Study NCT05790226



Ignite Creation Date: 2024-05-06 @ 6:49 PM
Last Modification Date: 2024-10-26 @ 2:55 PM
Study NCT ID: NCT05790226
Status: TERMINATED
Last Update Posted: 2024-05-08
First Post: 2023-01-25

Brief Title: Sentry Study Raman Spectroscopy on Ex Vivo Lungs
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: A Prospective Pre-Market Proof-of-Concept Study for Ex Vivo Raman Spectroscopy Measurements on Excised Lung Tissue With the Sentry System
Status: TERMINATED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Sponsor stopped study
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In this proof-of-concept ex vivo study the study team will investigate whether Raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue
Detailed Description: Lung cancer is the most prevalent form of cancer worldwide and the leading cause of cancer-related deaths Despite recent advances in treatment the five-year survival rate remains below 25 State of Lung Cancer Report 2021American Lung Association This is largely due to the fact that most patients are diagnosed only at advanced stages of the disease when treatments are ineffective and the prognosis is poor The National Lung Screening Trial demonstrated the utility of lung cancer screening by low-dose computed tomography CT to improve early detection and reduce lung cancer-related mortality by 20 Earlier detection of lung lesions in turn created an increased need for better early diagnosis modalities

Reveal Surgical is developing medical devices for tissue characterization based on Raman spectroscopy technology

In this proof-of-concept ex vivo study the study team will investigate whether Raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue

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