Recruiting

LaserEn

Sponsor:

University of Kansas Medical Center

Code:

NCT04979156

Conditions

Bladder Cancer

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

Study Details

Brief 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.

Conditions

Bladder Cancer

Surgery

Study ID

NCT04979156

Start date

Nov 4, 2021

Status verified date

Oct, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients must be 18 years of age or older.
2. Patient presenting for resection of papillary bladder tumor visualized on cystoscopy

1. New bladder tumor
2. Recurrent tumors
3. Tumor <3cm

Exclusion Criteria:

1. Patient unwilling to undergo en bloc resection
2. Non papillary lesions/tumors

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

Interventions

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 and Locations

Central contacts

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Oct 16, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2024-10-16.