Laser Treatment of Bladder Tumors in the Outpatient Depar... | NCT02659332

Studies
Laser Treatment of Bladder Tumors in the Outpatient Department

NCT02659332

Sponsor

Gregers G Hermann

Status

Unknown status

Last Update Posted

Jan 21, 2016Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Bladder Tumors

Interventions

TURBT

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Jan 15, 2016

First Submission Date that Met QC Criteria

Jan 19, 2016

First Posted Date

Jan 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gregers G Hermann, MD, DM Sc., Bispebjerg HospitalSponsor-Investigator

Lead Sponsor

Gregers G HermannOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TURBT	Experimental	Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms)	Device: TURBT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TURBT	Device	Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of 1 ms)	TURBT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete Removal by One Laser Treatment (Proportions of patients where the bladder tumors are completely removed by one laser)	Proportions of patients where the bladder tumors are completely removed by one laser treatment.	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recurrence of pTa low grade urothelial bladder tumor
Tumor < 1.5 cm
< 6 tumors

Exclusion Criteria:

Patients with porphyria
Known hypersensitivity to Hexvix® or porfhyrins
Use of any anticoagulantia
Macroscopic hematuria
Pregnant or breast feeding women
Expected poor compliance
Patients < 18 years
Patients who do not read or understand Danish

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregers G Hermann, MD, DMSc	Bispebjerg and Frederiksberg Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Bispebjerg and Frederiksberg Hospital		Frederiksberg	Copenhagen	2000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23485231	Background	Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.
15638895	Background	Sangar VK, Ragavan N, Matanhelia SS, Watson MW, Blades RA. The economic consequences of prostate and bladder cancer in the UK. BJU Int. 2005 Jan;95(1):59-63. doi: 10.1111/j.1464-410X.2005.05249.x.

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms