Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors
LaserIII
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?
1 other identifier
interventional
248
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedNovember 1, 2017
October 1, 2017
2.5 years
June 21, 2016
October 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor recurrence histological identified in biopsy obtained during cystoscopy
Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months
4 months
Secondary Outcomes (3)
Lower urinary symptoms caused by laser treatment.
2 weeks
Side effects to laser treatment.
2 weeks
Pain during laser treatment
Evaluated immediately after laser treatment
Study Arms (2)
Inpatient TUR-BT
ACTIVE COMPARATORTransurethral bladder tumor resection in operating theatre as inpatient.
laser bladder tumor destruction
EXPERIMENTALOutpatient laser mediated destruction of bladder tumors (LMD-BT)
Interventions
Conventional bladder tumor resection using diathermia
Laser mediated destruction of bladder tumors (LMD-BT)
Eligibility Criteria
You may qualify if:
- Ta low grade bladder tumor recurrences
- Up to a tumor size of 1,5 cm
- Up to 6 tumors
- Eligible patients for TUR-BT in GA
You may not qualify if:
- Patients with porphyria
- Known hypersensitivity to Hexvix® or porfhyrins
- Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
- Dementia
- Macroscopic hematuria
- Pregnant or breast feeding women
- Expected poor compliance estimated by the investigators
- Patients \< 18 years
- Patients who do not read or understand Danish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urological department, Frederiksberg Hospital
Copenhagen, 2000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregers G Hermann, DM Sc
Department of Urology, Frederiksberg hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Urologist
Study Record Dates
First Submitted
June 21, 2016
First Posted
September 1, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
November 1, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share