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Diode Laser Treatment of Bladder Tumors

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ClinicalTrials.gov Identifier: NCT02738827
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Gregers Gautier Hermann, University Hospital Bispebjerg and Frederiksberg

Brief Summary:

Laser treatment of pTa low grade bladder tumours in the outpatient department

Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.

Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).


Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Laser treatment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department.
Study Start Date : November 2015
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Laser treatment
Intervention is diode laser treatment of bladder cancer through a cystoscope without sedation of the patient.
Procedure: Laser treatment
Intervention is diode laser treatment of bladder cancer through a cystoscope in the outpatient department




Primary Outcome Measures :
  1. Tumour clearance [ Time Frame: 1 month ]
    No bladder tumor tissue in biopsies obtained from areas where a bladder tumor one month earlier has been removed by use of diode laser.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 porphyrins
  • Use of any anticoagulants
  • Macroscopic hematuria
  • Pregnant or breast feeding women
  • Expected poor compliance
  • Patients < 18 years
  • Patients who do not read or understand Danish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738827


Locations
Denmark
Urological department, Frederiksberg Hospital
Copenhagen, Denmark, 2000
Sponsors and Collaborators
Gregers Gautier Hermann
Investigators
Principal Investigator: Gregers G Hermann, MD Dept Urology, Herlev/Gentofte hospital, Copenhagen, Denmark

Responsible Party: Gregers Gautier Hermann, consultant urologist, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT02738827     History of Changes
Other Study ID Numbers: URU05
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases