LaserEn: SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT04979156
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors — PROCEDURE
    SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

Study Details

Conventional monopolar or bipolar transurethral resection of bladder tumors is the most common method for resection of a bladder mass. En bloc resection has demonstrated success in the literature utilizing different techniques and lasers, including utilizing the Ho:YAG and Tm:YAG lasers. A recent metanalysis revealed several benefits to laser en bloc resection including less complications and lower recurrence rate.22 Subsequently, laser technology has also advanced with the development of a super pulsed TFL which overcomes many limitations of prior traditional lasers. Olympus' SOLTIVE™ TFL, which has demonstrated improved maneuverability and control, has a shallow depth of tissue penetration at 0.15mm leading to precise resection and optimal hemostasis. Despite these beneficial characteristics and qualities along with the promising utility of en bloc resection, the Olympus SOLTIVE™ TFL has not been described in en bloc resection of bladder tumors. The investigator seek to determine if the proposed benefits of this device can be realized both pathologically and clinically in en bloc resection of bladder tumors.

Key Dates

Start date
Nov 4, 2021
Status verified
Oct 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
    SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

Primary Outcome Measure

To determine the ability to obtain identifiable pathologic characteristics of bladder tumor specimens by use the SOLTIVE™ laser during en bloc resection. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Jeffrey Holzbeierlein, MD (SUB_INVESTIGATOR)

Find similar trials in Kansas City, KS

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Kansas Medical Center· Kansas City, KS

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