Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899361
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-03-08
Brief Title:
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Study of a Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest for Surgical Dissection Within Urologic Regions of Interest
Status:
RECRUITING
Status Verified Date:
2023-10
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:
This research study is a pilot clinical trial which hypothesizes that the combination of electromagnetic tracking in conjunction with laparoscope imaging and ultrasound probe imaging will aid in reducing the complexity of both laparoscopic lymphadenectomy andor organ removal in patients with a confirmed diagnosis of cancer in urologic regions of interest Bladder Prostate Testicular Kidney Urethral and Penis by resulting in better visualization and more accurate localization of certain areas in the diseased organ or the diseased lymph node and allowing for improved surgical and patient outcomes fewer complications and better clinician performance
Detailed Description:
Participants in this research study may or may not have a tumor within a urologic region of interest such as the bladder prostate testicle kidney urethra and penis which may or may not have spread to a lymph node and have been scheduled to undergo a lymph node dissection procedure andor organ removal surgery within one of the previously mentioned urologic regions of interest concerning for urologic cancer
This research study involves the use of a standard of care laparoscope and ultrasound probe The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest
It is expected that the entire time to record the data will be less than 10 minutes
A total of 10 people will take part in this research study
This study is supported by Siemens Medical USA
This research study involves the use of a standard of care laparoscope and ultrasound probe The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest
It is expected that the entire time to record the data will be less than 10 minutes
A total of 10 people will take part in this research study
This study is supported by Siemens Medical USA
Study Oversight
Has Oversight DMC:
None
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?:
None