ClinicalTrials.gg
RecruitingNCT07898033Updated Oct 27, 2026

1 Year Recurrence After Modified en Bloc Resection (ERBT) vs Transurethral Resection (TURBT) for Large Bladder Tumors

A Phase 3 interventional study of En Bloc Resection of Bladder Tumor and Trans Urethral Resection of Bladder Tumor in NMIBC and TCC, sponsored by dmitry enikeev. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by dmitry enikeev · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

to compare pathological and oncological outcomes of TURBT versus ERBT in patients with bladder tumors sizes >2.5cm.

02

Conditions studied

03

In context

Non-Muscle Invasive Bladder Neoplasms

294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.

This study's planned enrollment of 136 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.

Browse Non-Muscle Invasive Bladder Neoplasms studies →

Lead sponsor

This is the only study on the registry with dmitry enikeev as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged ≥18 years with
  • Bladder tumor >2.5cm measured on US\CT\MRI (suspected non-muscle invasive bladder cancer).
  • Performance status () ≤2.
  • Signed form to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Multifocal tumors (≥4 lesions).
  • Prior history of BCG unresponsive bladder cancer.
  • Prior systemic chemotherapy or immunotherapy for any .
  • UTUC.
  • Evidence of disease.
  • for endoscopic surgery for bladder tumor.
  • Benign bladder tumor on postoperative pathology.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    ERBT

    patients undergoing ERBT surgery

    Procedure: En Bloc Resection of Bladder Tumor

  • Active comparator
    TURBT

    patients undergoing TURBT surgery

    Procedure: Trans Urethral Resection of Bladder Tumor

Interventions

  • ProcedureEn Bloc Resection of Bladder Tumor

    Trans-Urethral En Bloc Resection of Bladder Tumor using any energy source.

    Also known as: ERBT

  • ProcedureTrans Urethral Resection of Bladder Tumor

    The gold-standard Trans Urethral Resection of Bladder Tumor using mono\\bi-polar electrocautery

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. Detrusor muscle presence.

    The presence of Detrusor muscle in the specimen

    Time frame: Perioperative

  2. Diagnosis of muscle-invasive cancer on pathology

    Diagnosis of muscle-invasive cancer on pathology.

    Time frame: Perioperative

  3. Complications

    Intraoperative and early postoperative complications (Clavien-Dindo classification).

    Time frame: 30 days

  4. conversion to other technique

    Rate of conversion from ERBT to TURBT and vice versa

    Time frame: Perioperative

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2026
First posted
Oct 27, 2026
StartActual
Jun 8, 2026
Primary completionEst.
Jun 8, 2027
CompletionEst.
Jun 8, 2028
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07898033
Lead sponsor
dmitry enikeev
Collaborators
Rabin Medical Center, Vienna; University Hospital Vienna, Prince of Wales Hospital, Shatin, Hong Kong
Responsible party
dmitry enikeev (Clinical Professor, Rabin Medical Center) — Sponsor-investigator
First posted
Oct 27, 2026
Start date
Jun 8, 2026
Primary completion
Jun 8, 2027 (estimated)
Completion
Jun 8, 2028 (estimated)
Last update
Oct 27, 2026

Study contacts

Avishay Reuven Shem Tov Dlugy, MD
Contact
avishaishe@clalit.org.il
+972546648489

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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