Clinical trial · Interventional
Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors
Is Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors (LMD-BT) as Good as Conventional Inpatient PDD Guided Transurethral Tumor Resection in Patients With Low Grade Non-invasive (Ta) Bladder Tumors?
NCT02886026CI-TRIAL-00030159LaserIIIunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study compare the efficacy of conventional photodynamic (PDD) guided transurethral bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction of bladder tumors through flexible cystoscopes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bladder tumor resection using diathermia | Device | — | UNRESOLVED |
| Diode laser (980 nm) tumor destruction | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Inpatient TUR-BT
- description
- Transurethral bladder tumor resection in operating theatre as inpatient.
- interventionNames
- Device: Bladder tumor resection using diathermia
- type
- EXPERIMENTAL
- label
- laser bladder tumor destruction
- description
- Outpatient laser mediated destruction of bladder tumors (LMD-BT)
- interventionNames
- Device: Diode laser (980 nm) tumor destruction
Primary outcomes (1)
- measure
- Tumor recurrence histological identified in biopsy obtained during cystoscopy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ta low grade bladder tumor recurrences 2. Up to a tumor size of 1,5 cm 3. Up to 6 tumors 4. Eligible patients for TUR-BT in GA Exclusion Criteria: 1. Patients with porphyria 2. Known hypersensitivity to Hexvix® or porfhyrins 3. Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa 4. Dementia 5. Macroscopic hematuria 6. Pregnant or breast feeding women 7. Expected poor compliance estimated by the investigators 8. Patients \< 18 years 9. Patients who do not read or understand Danish
References
Publications (1)
- DERIVEDPedersen GL, Mogensen K, Rosthoj S, Erikson MS, Fode M, Hermann GG. In-Office Laser Coagulation of Ta Bladder Tumor Compared With Transurethral Resection of Bladder Tumor: 12 Months Follow-Up Randomized Clinical Trial. J Urol. 2026 May;215(5):535-543. doi: 10.1097/JU.0000000000004918. Epub 2025 Dec 29. PMID 41461083