Bladder CancerNCT04235764
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
An observational study of Bladder Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- modified resectoscope and TURBT
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bladder Cancer Patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
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.
Read more
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.
Read the detailed description
Background:
- Bladder cancer is the sixth most common cancer in the United States, disproportionately affecting more men than women.
- The gold standard for the surgical treatment and diagnosis of non-muscle invasive bladder cancer is transurethral resection of bladder tumors (TURBT).
- TURBT requires the fragmentation of bladder tumors and piecemeal removal of these tumors.
- TURBT leads to loss of histopathologic information - including tumor orientation, size, and margin status - which may compromise outcomes and risk tumor seeding within the bladder.
- Given these multiple problems with TURBT we are testing some modifications to the current resectoscope device and the effect of these modifications on the quality of TURBT specimens produced.
- The redesigned resectoscope device will be tested ex-vivo on cystectomy specimens to avoid risks to patient safety.
Objectives:
The primary objective of this study is to determine if resectoscope device modification can provide improved pathologic standards for the TURBT procedure. An improvement in any of the parameters outlined below will constitute a device improvement in the current resectoscope:
- Presence of three tissue layers within the tumor specimens containing bladder mucosa, lamina propria, and portions of the muscularis.
- Information regarding tumor margin, assessed as the ability to ascertain if tumor is present at the margin of the resection.
Eligibility:
- Medical condition requiring surgical removal of the bladder
- Men and women, age >= 18 years
Design:
- Preclinical tissue acquisition trial, ex vivo, proof-of-concept.
- Following cystectomy, a modified resectoscope/redesigned resectoscope will be used to resect areas of tumor from the cystectomy specimens. These resected tumors will be sent with the cystectomy specimen for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation.
- The remainder of the cystectomy specimens will undergo traditional histopathology. Histopathologic information from both specimens will be included in the final histopathologic diagnosis to ensure accurate oncology staging.
- This study will allow for about 2 years of accrual and the accrual ceiling will be set at 25 subjects.
- Conditions
- Bladder Cancer
- Being tested
- modified resectoscope, TURBT
- Keywords
- TURBT, Transurethral Resection of Bladder Tumors, Cystectomy, Modified Resectoscope, Natural History
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified resectoscopeDevice
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.
TURBTProcedure or surgery
All patients will receive routine surgical transurethral resection of bladder tumors (TURBT).
| Study group | Role | What they receive |
|---|---|---|
| 1/ Cohort 1 | Bladder Cancer Patients Receives: Device: modified resectoscope; Procedure: TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of resectoscope device modification on pathologic standards for the TURBT procedure
-Presence of three tissue layers with in the tumor specimens containing bladder mucosa, lamina propria, and portions of the muscularis.-Information regarding tumor margin, assessed as the ability to ascertain if tumor is present at the margin of the resection.
Measured: Time of surgery/pathologic assessment (7-10 days)
Secondary outcomes (1)
Assessment for possible bladder perforation in bladder specimens
The rate of occurrence will be described/tabulated.
Measured: Time of surgery/pathologic assessment (7-10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start9 Sep 2020
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Raju R Chelluri, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235764
- Sponsor's protocol ID
- 200020
- Other IDs
- 20-C-0020
- Status last verified
- 20 Oct 2026
- First submitted
- 18 Jan 2020
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
- ClinicalTrials.gov ID
- NCT04235764
- Acronym / sponsor ID
- 200020
- Conditions
- Bladder Cancer
- Keywords
- TURBT, Transurethral Resection of Bladder Tumors, Cystectomy, Modified Resectoscope, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Bladder cancer is the sixth most common cancer in the United States, disproportionately affecting more men than women.
- The gold standard for the surgical treatment and diagnosis of non-muscle invasive bladder cancer is transurethral resection of bladder tumors (TURBT).
- TURBT requires the fragmentation of bladder tumors and piecemeal removal of these tumors.
- TURBT leads to loss of histopathologic information - including tumor orientation, size, and margin status - which may compromise outcomes and risk tumor seeding within the bladder.
- Given these multiple problems with TURBT we are testing some modifications to the current resectoscope device and the effect of these modifications on the quality of TURBT specimens produced.
- The redesigned resectoscope device will be tested ex-vivo on cystectomy specimens to avoid risks to patient safety.
Objectives:
The primary objective of this study is to determine if resectoscope device modification can provide improved pathologic standards for the TURBT procedure. An improvement in any of the parameters outlined below will constitute a device improvement in the current resectoscope:
- Presence of three tissue layers within the tumor specimens containing bladder mucosa, lamina propria, and portions of the muscularis.
- Information regarding tumor margin, assessed as the ability to ascertain if tumor is present at the margin of the resection.
Eligibility:
- Medical condition requiring surgical removal of the bladder
- Men and women, age >= 18 years
Design:
- Preclinical tissue acquisition trial, ex vivo, proof-of-concept.
- Following cystectomy, a modified resectoscope/redesigned resectoscope will be used to resect areas of tumor from the cystectomy specimens. These resected tumors will be sent with the cystectomy specimen for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation.
- The remainder of the cystectomy specimens will undergo traditional histopathology. Histopathologic information from both specimens will be included in the final histopathologic diagnosis to ensure accurate oncology staging.
- This study will allow for about 2 years of accrual and the accrual ceiling will be set at 25 subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/ Cohort 1 | – | Device: modified resectoscope, Procedure: TURBTBladder Cancer Patients |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bladder Cancer Patients
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified resectoscopeThe 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. | Device | 1/ Cohort 1 |
| TURBTAll patients will receive routine surgical transurethral resection of bladder tumors (TURBT). | Procedure or surgery | 1/ Cohort 1 |
Primary outcome
Assessment of resectoscope device modification on pathologic standards for the TURBT procedure
Time frame: Time of surgery/pathologic assessment (7-10 days)
-Presence of three tissue layers with in the tumor specimens containing bladder mucosa, lamina propria, and portions of the muscularis.-Information regarding tumor margin, assessed as the ability to ascertain if tumor is present at the margin of the resection.
1 secondary outcome
Assessment for possible bladder perforation in bladder specimens
Time frame: Time of surgery/pathologic assessment (7-10 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raju R Chelluri, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NCI Medical Oncology Referral Office ((240) 760-6050, ncimo_referrals@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of resectoscope device modification on pathologic standards for the TURBT procedure (time frame: Time of surgery/pathologic assessment (7-10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.