RecruitingNCT04235764

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device


Sponsor

National Cancer Institute (NCI)

Enrollment

25 participants

Start Date

Sep 9, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Background: Bladder cancer is the sixth most common cancer in the United States. The way that doctors remove tumors in bladder surgeries may leave some cancer . Also, many people have their tumors return or progress after surgery. Researchers want to test a modified device. It might tell doctors more about bladder tumors. Objective: To see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens. Eligibility: People ages 18 and older who need to have their bladder removed at the NIH. Design: Participants will be screened with: Medical and prior surgical history Review of existing MRI, x-ray, or CT scans Review of existing specimens and reports Pregnancy test for women of childbearing age CT or MRI: Participants will lie in a machine. The machine will take pictures of their body. Participants will have bladder surgery. This will occur in the same way as if they did not take part in this study. A member of the research team will cut the removed bladder using the modified device. This will most likely be done on a separate back table in the operating room. The bladder and samples after cutting will be sent out for review. The will occur just as it would if the participants were not in this study. The only difference is the way that the specimen is prepared for review. Participants follow-up care will occur per standard of care. Or it will occur as part of any other study in which they might also be enrolled. ...


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is examining a surgical technique called en-bloc transurethral resection for removing bladder tumors, comparing it to the standard method to see if it results in better cancer removal and fewer complications. **You may be eligible if...** - You are any age (pediatric or adult) - You need surgical removal of your bladder (cystectomy) for either bladder cancer or a serious benign condition where your surgeon has recommended removal - You are healthy enough to undergo the planned surgery - You are able to give written informed consent **You may NOT be eligible if...** - You are pregnant (surgery during pregnancy poses significant risks) - You are unwilling or unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEmodified resectoscope

The modified resectoscope will be used post cystectomy (En-bloc TURBT) to resect areas of the tumor from the cystectomy specimen. These resected tumors will be sent for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation and compared to the remainder of the cystectomy specimens to see if the modified resectoscope can provide improved pathologic standards for the TURBT procedure.

PROCEDURETURBT

All patients will receive routine surgical transurethral resection of bladder tumors (TURBT).


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04235764


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