Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-03 @ 1:27 PM
Study NCT ID:
NCT02659332
Status:
UNKNOWN
Last Update Posted:
2016-01-21
First Post:
2016-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Treatment of Bladder Tumors in the Outpatient Department
Sponsor:
Gregers G Hermann
Organization:
Study Overview
Official Title:
Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department
Status:
UNKNOWN
Status Verified Date:
2016-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Primary Objective: To show that small pTa bladder tumors can be removed with diode laser in an outpatient department.
* Secondary Objective: To evaluate the patients' symptoms during and after the laser TURBT.
* Tertiary Objective: To evaluate the rate of remnant tumor tissue one month after the laser TURBT.
* Secondary Objective: To evaluate the patients' symptoms during and after the laser TURBT.
* Tertiary Objective: To evaluate the rate of remnant tumor tissue one month after the laser TURBT.
Detailed Description:
The patients will have a PDD guided flexible cystoscopy performed and the bladder tumor will be removed by a diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms).The treatment will take place in the OPD in awaken patients. One hour prior to the treatment the patient will have Hexvix® (photodynamic substance) and Lidocaine 20 ml (pain treatment) installed in the bladder. Simultaneous pain treatment will be oral Paracetamol 1 g and Ibuprofen 600 mg. Biopsy from the tumor will be taken to confirm the histological diagnosis.
Immediately after the procedure the pain assessed by the VAS score will be recorded and the patients are given a QOL questionnaire (EORTC QLQ-BLS24) and a stamped envelope and are asked to return it one week later. The patients will be telephoned after 5 days to remind on the questionnaire and to ash, whether they has had a urinary infection after the procedure.
One month after the laser TURBT a flexible PPD and SPIES guided cystoscopy is performed in the OPD to evaluate the laser efficacy. To confirm that all tumour tissue has been removed a biopsy will be taken from the previous tumor place. The biopsy will be send to the pathologist according to the normal procedure for biopsies. Visual presentation of the laser treated area will be visualized using PDD and SPIES.
Immediately after the procedure the pain assessed by the VAS score will be recorded and the patients are given a QOL questionnaire (EORTC QLQ-BLS24) and a stamped envelope and are asked to return it one week later. The patients will be telephoned after 5 days to remind on the questionnaire and to ash, whether they has had a urinary infection after the procedure.
One month after the laser TURBT a flexible PPD and SPIES guided cystoscopy is performed in the OPD to evaluate the laser efficacy. To confirm that all tumour tissue has been removed a biopsy will be taken from the previous tumor place. The biopsy will be send to the pathologist according to the normal procedure for biopsies. Visual presentation of the laser treated area will be visualized using PDD and SPIES.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: