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NCT04784507
En-Bloc Resection of Bladder Tumors
Phase 2 trial testing En Bloc Resection in Bladder Neoplasm in 60 participants. Status unknown.
31 May 2022
Quick facts
| Lead sponsor | Betul Kartal |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 60 |
| Start date | 1 April 2020 |
| Primary completion | 31 May 2022 |
| Estimated completion | 30 July 2022 |
| Sites | 2 locations across Turkey (Türkiye) |
Drugs / interventions tested
- En Bloc Resection
- Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)
Conditions studied
- Bladder Neoplasm — all drugs for Bladder Neoplasm →
Sponsor
Betul Kartal
Who can join
18 and older, any sex, with Bladder Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Observational data shows that "en bloc" resection of bladder tumor (EBR-BT) may entail advantages when compared with conventional transurethral bladder tumor resection (TURBT). EBR-BT has the potential to increase the rate of correct staging and accurate assignment of risk-classification in non-muscle-invasive bladder cancer (NMIBC) and to avoid re-TURBT in a considerable number of high-grade NMIBC by demonstrating total macro and microscopic eradication of the primary tumor and to provide the basis for a correct treatment based on a correct stage. Following the rules of the IDEAL collaboration evaluation and stages of surgical innovation and considering EBR-BT as a surgical technical innovation, the investigators designed a multi-institutional, stage 2a/b study on feasibility (procedural success), safety (including pathology features), and short-term efficacy of EBR-BT and as proof of concept on the reliability of NMIBC staging. Main objective: to prospectively assess the pathological efficacy of EBR-BT in the staging of bladder cancer and the clinical efficacy at short-term recurrence-free survival. Secondary objectives: To assess the clinical efficacy at short-term (3-months) of EBR-BT, and to compare efficacy in the staging of the EBR-BT with the conventional TURBT.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT04784507
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04784507 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Betul Kartal
- Last refreshed: 12 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04784507.
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