NMIBCPhase 3NCT07898033
1 Year Recurrence After Modified en Bloc Resection (ERBT) vs Transurethral Resection (TURBT) for Large Bladder Tumors
A Phase 3 study testing En Bloc Resection of Bladder Tumor and Trans Urethral Resection of Bladder Tumor in people with NMIBC and TCC, run by dmitry enikeev at 1 site in Israel.
Trial summary
to compare pathological and oncological outcomes of TURBT versus ERBT in patients with bladder tumors sizes >2.5cm. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- En Bloc Resection of Bladder Tumor and Trans Urethral Resection of Bladder Tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Jun 2026to 8 Jun 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years with
- Bladder tumor >2.5cm measured on US\CT\MRI (suspected non-muscle invasive bladder cancer).
- Performance status (ECOG) ≤2.
- Signed informed consent form to participate in the study
Who cannot join
- Multifocal tumors (≥4 lesions).
- Prior history of BCG unresponsive bladder cancer.
- Prior systemic chemotherapy or immunotherapy for any malignancy.
- UTUC.
- Evidence of metastatic disease.
- Contraindications for endoscopic surgery for bladder tumor.
- Benign bladder tumor on postoperative pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Avishay Reuven Shem Tov Dlugy, MD, +972546648489, avishaishe@clalit.org.il
Dmitry Enikeev, Profesor
About this study
Official title: A Randomized Controlled Trial Comparing 1 Year Recurrence After Modified en Bloc Resection (ERBT) and Transurethral Resection (TURBT) for Large Bladder Tumors >2.5cm
to compare pathological and oncological outcomes of TURBT versus ERBT in patients with bladder tumors sizes >2.5cm.
- Being tested
- En Bloc Resection of Bladder Tumor, Trans Urethral Resection of Bladder Tumor
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En Bloc Resection of Bladder TumorProcedure or surgery
Also called ERBT
Trans-Urethral En Bloc Resection of Bladder Tumor using any energy source.
Trans Urethral Resection of Bladder TumorProcedure or surgery
The gold-standard Trans Urethral Resection of Bladder Tumor using mono\bi-polar electrocautery
| Study group | Role | What they receive |
|---|---|---|
| ERBT | Experimental | patients undergoing ERBT surgery Receives: Procedure: En Bloc Resection of Bladder Tumor |
| TURBT | Active comparator | patients undergoing TURBT surgery Receives: Procedure: Trans Urethral Resection of Bladder Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 months Recurrence
Recurrence defined as presence of visible signs of tumor relapse at the follow-up cystoscopy 12 months after the initial surgery; recurrence needs to be confirmed by tissue diagnosis.
Measured: 12 months
Secondary outcomes (4)
Detrusor muscle presence.
The presence of Detrusor muscle in the specimen
Measured: Perioperative
Diagnosis of muscle-invasive cancer on pathology
Diagnosis of muscle-invasive cancer on pathology.
Measured: Perioperative
Complications
Intraoperative and early postoperative complications (Clavien-Dindo classification).
Measured: 30 days
conversion to other technique
Rate of conversion from ERBT to TURBT and vice versa
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start8 Jun 2026
- Primary completion8 Jun 2027 (estimated)
- Study completion8 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dmitry enikeev
- Sponsor type
- University, hospital or other
- Collaborators
- Rabin Medical Center, Vienna; University Hospital Vienna, Prince of Wales Hospital, Shatin, Hong Kong
- Responsible party
- Sponsor-investigator, dmitry enikeev, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898033
- Sponsor's protocol ID
- 0501-25-RMC
- Other IDs
- MOH_2026-06-04_016864
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing 1 Year Recurrence After Modified en Bloc Resection (ERBT) and Transurethral Resection (TURBT) for Large Bladder Tumors >2.5cm
- ClinicalTrials.gov ID
- NCT07898033
- Acronym / sponsor ID
- 0501-25-RMC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- dmitry enikeevUniversity, hospital or other
- Collaborators
- Rabin Medical Center, Vienna; University Hospital Vienna, Prince of Wales Hospital, Shatin, Hong Kong
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 8 Jun 2027 (estimated)
- Study completion
- 8 Jun 2028 (estimated)
- First posted
- 27 Oct 2026 (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.
to compare pathological and oncological outcomes of TURBT versus ERBT in patients with bladder tumors sizes >2.5cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERBT | Experimental | Procedure: En Bloc Resection of Bladder Tumorpatients undergoing ERBT surgery |
| TURBT | Active comparator | Procedure: Trans Urethral Resection of Bladder Tumorpatients undergoing TURBT surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years with
- Bladder tumor >2.5cm measured on US\CT\MRI (suspected non-muscle invasive bladder cancer).
- Performance status (ECOG) ≤2.
- Signed informed consent form to participate in the study
Key exclusion criteria (7 listed)
- Multifocal tumors (≥4 lesions).
- Prior history of BCG unresponsive bladder cancer.
- Prior systemic chemotherapy or immunotherapy for any malignancy.
- UTUC.
- Evidence of metastatic disease.
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 |
|---|---|---|
| En Bloc Resection of Bladder TumorAlso: ERBTTrans-Urethral En Bloc Resection of Bladder Tumor using any energy source. | Procedure or surgery | ERBT |
| Trans Urethral Resection of Bladder TumorThe gold-standard Trans Urethral Resection of Bladder Tumor using mono\bi-polar electrocautery | Procedure or surgery | TURBT |
Primary outcome
12 months Recurrence
Time frame: 12 months
Recurrence defined as presence of visible signs of tumor relapse at the follow-up cystoscopy 12 months after the initial surgery; recurrence needs to be confirmed by tissue diagnosis.
4 secondary outcomes
Detrusor muscle presence.
Time frame: Perioperative
Diagnosis of muscle-invasive cancer on pathology
Time frame: Perioperative
Complications
Time frame: 30 days
conversion to other technique
Time frame: Perioperative
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 27 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing En Bloc Resection of Bladder Tumor and Trans Urethral Resection of Bladder Tumor in people with NMIBC and TCC, run by dmitry enikeev at 1 site in Israel.
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 4 inclusion and 7 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 27 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 Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Avishay Reuven Shem Tov Dlugy, MD (+972546648489, avishaishe@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 months Recurrence (time frame: 12 months). 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 27 Oct 2026.