RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-04
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04979156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients must be 18 years of age or older.
  2. 2. Patient presenting for resection of papillary bladder tumor visualized on cystoscopy
  3. 1. New bladder tumor
  4. 2. Recurrent tumors
  5. 3. Tumor \<3cm
  1. 1. Patient unwilling to undergo en bloc resection
  2. 2. Non papillary lesions/tumors

Contacts and Locations

Study Contact

Jane Ledesma
CONTACT
9135888721
jledesma2@kumc.edu

Principal Investigator

Jeffrey Holzbeierlein
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center
Kansas City, Kansas, 66160
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Jeffrey Holzbeierlein, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-04
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-11-04
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Bladder Cancer
  • Surgery