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Procedure
Surgical Guidance Technology for Urologic Cancer Surgery
N/A
Recruiting
Led By Matthew Mossanen, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be scheduled to undergo lymphadenectomy for a urologic cancer within the urologic regions of interest: Bladder, Prostate, Testicular, Kidney, Urethral, and Penile
Subjects aged ≥ 18 years with a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month, up to 45 days from registration
Awards & highlights
Study Summary
This trial is testing two different ways to guide surgeons during cancer surgery to remove lymph nodes.
Who is the study for?
This trial is for adults over 18 with confirmed or suspected urologic cancers (bladder, prostate, testicular, kidney, urethral, penile) who need lymph node removal surgery. They must have had a recent quality imaging scan at Brigham and Women's Hospital and be able to undergo general anesthesia without significant health risks.Check my eligibility
What is being tested?
The study compares two navigation systems: the 3D Slicer-based system and the Siemens Monaco system. These are used during laparoscopic lymphadenectomy (lymph node removal surgery) to see if they can make this complex procedure simpler for patients with urological cancer.See study design
What are the potential side effects?
While specific side effects aren't listed for the navigation systems being tested, typical risks of laparoscopic lymphadenectomy may include bleeding, infection, pain at incision sites, possible damage to nearby organs or tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a lymph node removal surgery for cancer in my bladder, prostate, testicle, kidney, urethra, or penis.
Select...
I am over 18 and have a possible diagnosis needing a biopsy in my urinary system.
Select...
I am scheduled for a laparoscopic lymph node removal in the AMIGO operating room.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month, up to 45 days from registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month, up to 45 days from registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Patients Completing Intended Procedure (Feasibility)
Secondary outcome measures
Acceleration Kinematic Metric
Further, the pathology of the lymph node resected using the navigation system will be compared to the other lymph nodes resected in urologic regions of interest.
Jerk Kinematic Metric
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Urologic Lymphadenectomy in AMIGOExperimental Treatment2 Interventions
Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,713 Total Patients Enrolled
Matthew Mossanen, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have general anesthesia due to health risks.I am scheduled for a lymph node removal surgery for cancer in my bladder, prostate, testicle, kidney, urethra, or penis.My kidney function is severely impaired.I am over 18 and have a possible diagnosis needing a biopsy in my urinary system.I am scheduled for a laparoscopic lymph node removal in the AMIGO operating room.
Research Study Groups:
This trial has the following groups:- Group 1: Urologic Lymphadenectomy in AMIGO
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients still being accepted into this clinical experiment?
"The clinicaltrials.gov record for this trial indicates that it is not currently seeking participants; the initial post was made on April 1st, 2022 and updated recently on November 11th 2021. However, 683 other medical trials are still open to recruitment at present time."
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