NCT02738827

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

December 21, 2015

Last Update Submit

May 30, 2017

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumour clearance

    No bladder tumor tissue in biopsies obtained from areas where a bladder tumor one month earlier has been removed by use of diode laser.

    1 month

Study Arms (1)

Laser treatment

OTHER

Intervention is diode laser treatment of bladder cancer through a cystoscope without sedation of the patient.

Procedure: Laser treatment

Interventions

Laser treatmentPROCEDURE

Intervention is diode laser treatment of bladder cancer through a cystoscope in the outpatient department

Laser treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urological department, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Gregers G Hermann, MD

    Dept Urology, Herlev/Gentofte hospital, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
consultant urologist

Study Record Dates

First Submitted

December 21, 2015

First Posted

April 14, 2016

Study Start

November 1, 2015

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)