Trials / Recruiting
RecruitingNCT05899361
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 and/or 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 and/or 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.
Conditions
- Urologic Cancer
- Urologic Neoplasms
- Bladder Cancer
- Prostate Cancer
- Testicular Cancer
- Kidney Cancer
- Urethral Cancer
- Penile Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Electromagnetic Guided Laparoscopy | Standard Care |
| DEVICE | Ultrasound | Standard Care |
Timeline
- Start date
- 2023-08-30
- Primary completion
- 2025-08-26
- Completion
- 2026-12-25
- First posted
- 2023-06-12
- Last updated
- 2023-10-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05899361. Inclusion in this directory is not an endorsement.