Laser Treatment of Bladder Tumors in the Outpatient Department

January 20, 2016 updated by: Gregers G Hermann

Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Frederiksberg, Copenhagen, Denmark, 2000
        • Department of Urology, Bispebjerg and Frederiksberg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TURBT
Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms)
Device: TURBT
Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of 1 ms)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gregers G Hermann

Investigators

  • Principal Investigator: Gregers G Hermann, MD, DMSc, Bispebjerg and Frederiksberg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URU05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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