Assessing the safety and effectiveness of a biopsy instrument when sampling tumours in the urinary bladder

Safety and efficacy of the EndoDrill® Uro X biopsy instrument when sampling tumours in the urinary bladder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN80990426

Enrollment

Registered

2020-09-10

Start date

2020-10-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer Cancer Malignant neoplasm of bladder

Interventions

Method of randomisation: closed envelopes Conventional arm: standard transurethral resection Experimental arm: endoscopic biopsy under local anesthesia with the Urodrill instrument

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of written informed consent 2. =18 years of age 3. Patients attending participating urology departments for haematuria investigation and CT-urography suspicious of muscle-invasive bladder cancer

Exclusion criteria

Exclusion criteria: 1. Patients unable or unwilling to undergo EndoDrill biopsy 2. Bleeding diathesis prohibiting EndoDrill biopsies 3. Ongoing immunosuppression (except corticosteroids in moderate doses, less than 10 mg prednisolone or equivalent daily) 4. Patients not suitable/fit for radical treatment for MIBC 5. Pregnancy

Design outcomes

Primary

Measure	Time frame
Time from radiological suspicion of MIBC to start of definitive treatment for MIBC (neoadjuvant chemotherapy and/or cystectomy): measured using prospective registration at day for radiological report stating suspicion of MIBC to starting day of neoadjuvant chemotherapy, or cystectomy for those operated without neoadjuvant chemotherapy by prospective registration	—

Secondary

Measure	Time frame
1. Complications from the EndoDrill biopsy procedure assessed by a structured telephone interview 2 weeks after the procedure 2. Proportion of patients with MIBC that the EndoDrill® Uro X -instrument failed to detect, but diagnosed with ordinary TURBT, measured using pathology at [at secondary procedure with TURBT for those in the experimental arm without verification of MIBC and with MIBC verified by TURBT 3. Proportion of patients with successful molecular classification based on RNA sequencing performed in real time with 6 weeks of sampling in both arms 4. Cancer-specific survival (CSS) measured using chart review at 24 months after initiating definitive treatment for MIBC 5. Overall proportion of patients who correctly followed the protocol and were staged as MIBC in the intervention arm, measured using chart review within 3 months of inclusion 6. Cost-effectiveness based on EQ5D5L at baseline and 2 weeks 7. Quality of life measured using FACT-G questionnaire preoperatively and FACT-VCI at 12 months 8. Adverse events assessed during a phone interview by a research nurse 2 weeks after the procedures 9. Sensitivity and specificity for CT-urography and MRI respectively to accurately determine muscle-invasive bladder cancer compared to the outcome of the combined measure of biopsy and cystectomy specimen, measured using sensitivity calculations compared to pathology within 3 months of inclusion	—

Measure

Time frame

1. Complications from the EndoDrill biopsy procedure assessed by a structured telephone interview 2 weeks after the procedure 2. Proportion of patients with MIBC that the EndoDrill® Uro X -instrument failed to detect, but diagnosed with ordinary TURBT, measured using pathology at [at secondary procedure with TURBT for those in the experimental arm without verification of MIBC and with MIBC verified by TURBT 3. Proportion of patients with successful molecular classification based on RNA sequencing performed in real time with 6 weeks of sampling in both arms 4. Cancer-specific survival (CSS) measured using chart review at 24 months after initiating definitive treatment for MIBC 5. Overall proportion of patients who correctly followed the protocol and were staged as MIBC in the intervention arm, measured using chart review within 3 months of inclusion 6. Cost-effectiveness based on EQ5D5L at baseline and 2 weeks 7. Quality of life measured using FACT-G questionnaire preoperatively and FACT-VCI at 12 months 8. Adverse events assessed during a phone interview by a research nurse 2 weeks after the procedures 9. Sensitivity and specificity for CT-urography and MRI respectively to accurately determine muscle-invasive bladder cancer compared to the outcome of the combined measure of biopsy and cystectomy specimen, measured using sensitivity calculations compared to pathology within 3 months of inclusion

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026