10 Participants NeededMy employer runs this trial

Ureteroscopy for Urothelial Cancer

MU
Overseen ByMichael Uy, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assess upper tract urothelial carcinoma (a type of cancer in the urinary system) using a thin camera called a ureteroscope. Traditionally performed in an operating room with general anesthesia, this procedure will now take place in a doctor's office with a special ultra-thin ureteroscope. This aims to make the process easier and more comfortable for patients. The goal is to determine if this office-based approach, known as Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope, can effectively diagnose the cancer while reducing anesthesia-related risks. Individuals who have previously managed this type of cancer or have a suspected diagnosis based on imaging might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cancer diagnosis methods.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this office-based ureteroscopy is safe for assessing upper tract urothelial carcinoma?

Research has shown that using a single-use digital flexible ureteroscope for examining the urinary tract is generally safe. Studies have found this method effective for treating kidney and ureter stones, with a strong safety record. Most people tolerate the procedure well, and serious issues rarely occur. Although some reports mention technical problems like malfunction or breakage, these typically do not affect patient safety. A single-use device also reduces the risk of infection compared to reusable ones. Overall, this method appears safe for diagnosing and treating cancer in the upper urinary tract.12345

Why are researchers excited about this trial?

Researchers are excited about the office-based ureteroscopy using a single-use digital, flexible ureteroscope for treating urothelial cancer because it offers a more convenient and potentially less invasive approach compared to traditional methods. Unlike standard treatments that often require hospital visits and more extensive procedures, this technique can be performed in an office setting with local anesthesia. This could lead to reduced patient discomfort, quicker recovery times, and lower healthcare costs. By utilizing a digital, flexible ureteroscope, doctors can achieve precise and effective visualization of the urinary tract, which enhances diagnostic accuracy.

What evidence suggests that office-based ureteroscopy using a single use digital, flexible ureteroscope is effective for assessing upper tract urothelial carcinoma?

This trial will evaluate the effectiveness of a single-use digital flexible ureteroscope for procedures in a doctor's office to check for upper tract urothelial carcinoma, a type of cancer in the urinary system lining. Studies have shown that this method performs as well as traditional reusable ureteroscopes used in operating rooms. The single-use ureteroscope also enhances safety by reducing infection risk. Additionally, it avoids the complications of general anesthesia, as the procedure uses local anesthesia in a doctor's office. Early findings suggest that this approach can quickly and comfortably assess the condition, aiding in timely diagnosis and treatment planning.12467

Who Is on the Research Team?

KG

Khurshid Ghani, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with a known or suspected upper tract urothelial carcinoma (a type of urinary tract cancer) who need an assessment. Participants should be able to undergo a procedure in the doctor's office and not require general anesthesia.

Inclusion Criteria

Provision of signed and dated informed consent form
Ability and willingness to complete and adhere to survey questions and responses throughout study duration
I am willing and able to follow all study procedures for the entire study period.
See 2 more

Exclusion Criteria

Pregnancy
I have been diagnosed with ureteral strictures.
I currently have a urinary tract infection.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo office-based ureteroscopy using a 6.3 French single use digital flexible ureteroscope

1 day
1 visit (in-person)

Immediate Post-Procedure

Participants receive pain medication as needed and are monitored for immediate post-procedure outcomes

1 day

Follow-up

Participants are monitored for pain, satisfaction, and unplanned healthcare use

30 days
Follow-up assessments at 7-10 days and up to 30 days post-procedure

What Are the Treatments Tested in This Trial?

Interventions

  • Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope

Trial Overview

The study tests using an ultra-thin, single-use digital flexible ureteroscope during office visits to examine the urinary tract for cancer. It compares this approach to traditional methods that use larger scopes and general anesthesia.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Diagnostic (in office ureteroscopy)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Shenzhen HugeMed Medical Technical Development

Collaborator

Citations

Single-Use vs. Reusable Digital Flexible Ureteroscope to ...

The purpose of this research was to compare the treatment outcomes and costs of a single-use and reusable digital flexible ureteroscope for upper urinary ...

Office-Based Ureteroscopy Utilizing a Single Use Digital ...

This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment ...

Office-Based Ureteroscopy Utilizing a Single Use Digital, ...

This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of ...

Economic evaluation of a single use flexible digital ureteroscope

The goal of our study is to analyze the possible economic benefits of single-use flexible ureteroscopes (su-fURSs) and compare their cost ...

LithoVue™ Single-Use Digital Flexible Ureteroscope

In a cost analysis, it was determined that. 46%–59% of the cost of maintaining a flexible ureteroscopy program results from ureteroscope damage. Knudsen B, ...

CAPABILITIES OF A 6.3FR SINGLE-USE DIGITAL ...

The advent of flexible ureteroscopy (URS) has transformed endourology, enabling safe and effective management of renal stones and upper tract ...

LithoVue™ Single-Use Digital Flexible Ureteroscope

It delivers detailed high-resolution digital images for high-quality visualization and navigation – to help you remove stones quickly, safely and affordably.