Using a modified device for bladder tumor surgery
Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
This study is testing a new surgical tool for bladder tumor surgery to see if it can help doctors get better information about the tumors to improve treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT04235764 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a redesigned surgical resectoscope device used during transurethral resection of bladder tumors (TURBT) to improve the quality of tumor specimens. The modified device is expected to provide better histopathologic information by preserving tumor orientation, size, and margin status, which are critical for treatment outcomes. Participants will undergo standard bladder surgery while the modified device is tested ex-vivo on cystectomy specimens to assess its effectiveness without compromising patient safety. The study will involve screening participants based on their medical history and imaging results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require surgical removal of the bladder due to cancer or other conditions.
Not a fit: Patients with non-invasive bladder cancer or those not requiring bladder removal may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced tumor recurrence for bladder cancer patients.
How similar studies have performed: While the approach of modifying surgical devices is not entirely novel, the specific application of this redesigned resectoscope for bladder cancer surgery has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Patients requiring surgical removal of the bladder at the NIH Clinical Center. NOTE: Reasons for need for surgical removal of bladder include cancer or benign condition for which a surgeon determined surgical removal of the bladder is recommended. Patient's with invasive bladder cancer requiring cystectomy are eligible for enrollment. Bladder cancer remains the most common reason for cystectomy. Patients with clinical advanced disease and having other treatments/or participating in other trials remain eligible for enrollment in this study. * Men and women * Age greater than or less than 18 years * Deemed clinically appropriate for the planned surgical procedure. * Ability of subject to understand and the willingness to sign a written informed consent document. * Subjects will be asked to co-enroll in 15-C-0087, "Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens from Healthy Volunteers and Urothelial Cancer Patients." NOTE: Most participants are expected to already be enrolled in 15-C-0087 prior to entry in this study. EXCLUSION CRITERIA: \- Cystectomy during pregnancy would subject the fetus to significant risk of miscarriage or premature labor. For this reason, pregnant women are ineligible for this study.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Raju R Chelluri, M.D. — National Cancer Institute (NCI)
- Study coordinator: NCI Medical Oncology Referral Office
- Email: ncimo_referrals@nih.gov
- Phone: (240) 760-6050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.