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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must be 18 years of age or older.

• Patient presenting for resection of papillary bladder tumor visualized on cystoscopy

‣ New bladder tumor

⁃ Recurrent tumors

• Tumor \<3cm

Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Jane Ledesma
jledesma2@kumc.edu
9135888721
Time Frame
Start Date: 2021-11-04
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 20
Treatments
SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
Authors
Jeff Holzbeierlein
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov

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