NCT02659332

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

January 15, 2016

Last Update Submit

January 20, 2016

Conditions

Bladder Tumors

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

TURBT

EXPERIMENTAL

Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms)

Device: TURBT

Interventions

TURBTDEVICE

Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of 1 ms)

TURBT

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Bispebjerg and Frederiksberg Hospital

Frederiksberg, Copenhagen, 2000, Denmark

Location

Related Publications (10)

  • 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.

    PMID: 23485231BACKGROUND

  • 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.

    PMID: 15638895BACKGROUND

  • van Rhijn BW, Burger M, Lotan Y, Solsona E, Stief CG, Sylvester RJ, Witjes JA, Zlotta AR. Recurrence and progression of disease in non-muscle-invasive bladder cancer: from epidemiology to treatment strategy. Eur Urol. 2009 Sep;56(3):430-42. doi: 10.1016/j.eururo.2009.06.028. Epub 2009 Jun 26.

    PMID: 19576682BACKGROUND

  • James AC, Gore JL. The costs of non-muscle invasive bladder cancer. Urol Clin North Am. 2013 May;40(2):261-9. doi: 10.1016/j.ucl.2013.01.004. Epub 2013 Feb 13.

    PMID: 23540783BACKGROUND

  • Hofstetter A, Frank F, Keiditsch E, Bowering R. Endoscopic Neodymium-YAG laser application for destroying bladder tumors. Eur Urol. 1981;7(5):278-82. doi: 10.1159/000473240.

    PMID: 6894732BACKGROUND

  • Davenport K, Keeley FX Jr, Timoney AG. Audit of safety, efficacy, and cost-effectiveness of local anaesthetic cystodiathermy. Ann R Coll Surg Engl. 2010 Nov;92(8):706-9. doi: 10.1308/003588410X12699663904835. Epub 2010 Jul 2.

    PMID: 20615299BACKGROUND

  • Syed HA, Talbot N, Abbas A, MacDonald D, Jones R, Marr TJ, Rukin NJ. Flexible cystoscopy and Holmium:Yttrium aluminum garnet laser ablation for recurrent nonmuscle invasive bladder carcinoma under local anesthesia. J Endourol. 2013 Jul;27(7):886-91. doi: 10.1089/end.2012.0696. Epub 2013 Jun 22.

    PMID: 23537221BACKGROUND

  • Wong KA, Zisengwe G, Athanasiou T, O'Brien T, Thomas K. Outpatient laser ablation of non-muscle-invasive bladder cancer: is it safe, tolerable and cost-effective? BJU Int. 2013 Sep;112(5):561-7. doi: 10.1111/bju.12216. Epub 2013 Jul 2.

    PMID: 23819486BACKGROUND

  • Hermann GG, Mogensen K, Toft BG, Glenthoj A, Pedersen HM. Outpatient diagnostic of bladder tumours in flexible cystoscopes: evaluation of fluorescence-guided flexible cystoscopy and bladder biopsies. Scand J Urol Nephrol. 2012 Feb;46(1):31-6. doi: 10.3109/00365599.2011.637954. Epub 2011 Dec 12.

    PMID: 22150596BACKGROUND

  • Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006 Dec;203(6):865-77. doi: 10.1016/j.jamcollsurg.2006.08.026.

    PMID: 17116555BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gregers G Hermann, MD, DMSc

    Bispebjerg and Frederiksberg Hospital

    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
MD, DM Sc.

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

DK(1)