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Bladder TumorsNCT02659332

Laser Treatment of Bladder Tumors in the Outpatient Department

A study testing TURBT in people with Bladder Tumors, run by Gregers G Hermann at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Tumors
What is being tested?
TURBT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
Feb 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Urology, Bispebjerg and Frederiksberg Hospital

    Frederiksberg, Copenhagen, 2000

Other trials in Denmark

About this study

Official title: 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.
Read the 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.

Conditions
Bladder Tumors
Being tested
TURBT
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TURBTDevice

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

Study groups in NCT02659332
Study groupRoleWhat they receive
TURBTExperimentalDiode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms)
Receives: Device: TURBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2016 (estimated)
  2. Study startFeb 2015
  3. Primary completionMar 2016 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02659332
Sponsor's protocol ID
URU05
Status last verified
Jan 2016
First submitted
15 Jan 2016
Last updated
21 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23485231

  • 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.

    PubMed 15638895

  • 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.

    PubMed 19576682

  • 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.

    PubMed 23540783

  • 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.

    PubMed 6894732

  • 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.

    PubMed 20615299

  • 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.

    PubMed 23537221

  • 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.

    PubMed 23819486

  • 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.

    PubMed 22150596

  • 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.

    PubMed 17116555

Questions about this trial

What is this clinical trial studying?

A study testing TURBT in people with Bladder Tumors, run by Gregers G Hermann at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Removal by One Laser Treatment (Proportions of patients where the bladder tumors are completely removed by one laser) (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02659332, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.

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