NCT04110483

Thulium Fiber Laser En-bloc Resection vs Conventional Transurethral Resection of Non-muscle-invasive Bladder Cancer

Completed NA Last updated 18 February 2020

What this trial tests

NA trial testing Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer in Bladder Cancer in 130 participants. Completed in 31 December 2018.

Timeline

1 January 2015

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	I.M. Sechenov First Moscow State Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	130
Start date	1 January 2015
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across Russia

Drugs / interventions tested

• Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer
• Transurethral resection of non-muscle-invasive bladder cancer

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

I.M. Sechenov First Moscow State Medical University

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ongoing efforts aim at overcoming the challenges of conventional transurethral resection of bladder tumor (TURBT) such as the high recurrence rate, difficulty of pathologic interpretation and complications including wall injury. Possible advantages may have en bloc resection of bladder tumor which was previously shown to be effective and safe technique. Use of novel thulium-fiber laser may also provide additional safety and efficacy of the resection.

Objective. To prospective assess the safety and efficacy of Thulium-fiber en bloc resection of bladder tumor (Tm-fiber-ERBT) compared to TURBT.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.