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

NCT04979156 | Recruiting

• 1 other identifier: LaserEn
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To determine the ability to obtain identifiable pathologic characteristics of bladder tumor specimens by use the SOLTIVE™ laser during en bloc resection.

  To determine the ability to obtain identifiable pathologic characteristics of bladder tumor specimens by use the SOLTIVE™ laser during en bloc resection.

  6 months

Secondary Outcomes (3)

• To evaluate the overall recurrence rate as well as the recurrence rate at the prior resection site after SOLTIVE™ en bloc resection of bladder tumors.

  6 months

• To evaluate patient symptoms before and after en bloc tumor resection

  6 months

• • To evaluate short-term complications within 3 months after SOLTIVE™ en bloc resection of bladder tumors.

  6 months

Study Arms (1)

SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

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

Interventions

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

SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

Also known as: TURBT En Bloc

SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are undergoing resection of the bladder for bladder tumors.

You may qualify if:

• 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

You may not qualify if:

• Patient unwilling to undergo en bloc resection
• Non papillary lesions/tumors

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jeffrey Holzbeierlein

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Ledesma

CONTACT

9135888721; jledesma2@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 28, 2021
• Study Start: November 4, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)