Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT04979156
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2021-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LaserEn: SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
LaserEn: SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LaserEn
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.
Detailed Description:
This is a prospective study investigating the use of the SOLTIVE™ Thulium Super pulse laser for the treatment of bladder tumors via en bloc resection in patients who present for treatment at the University of Kansas Health System. The study pretreatment evaluation and follow up schedule are the same as used routinely in daily practice, in accordance with standard of care practices. Routine labs (e.g. complete blood count, basic or complete metabolic panel, urinalysis and urine culture), and imaging will be obtained as per standard care at the provider's discretion based on the patient's history and physical exam.
A prospective data collection of the patients with bladder cancer undergoing en bloc resection will be conducted in this study.
A complete medical, surgical and bladder cancer history will be obtained by the surgical team in the pre-operative setting, per standard of care practices.
Patients will be taken to the operating room per standard of care for resection of one or more bladder tumors. The SOLTIVE™ Super Pulsed Thulium laser will be utilized for resection of the tumors in an en bloc fashion.
Technique for en bloc resection of bladder tumor Tumor marked with a circular coagulation blockage border approximately 1.0 cm away from the edge. All visible vessels around the tumor will be coagulated and lasered before the incision to reduce bleeding. Along this mark, a fan-shaped incision into the bladder wall is made until the muscle layer is visible uplift tumor by the force of the irrigation and use of the laser tip, gradually exposing the tumor base tumor base is disconnected tumor is then removed en bloc. If it is unable to be removed through the resectoscope in one piece due to its size, it may be cut into 2 pieces at the surgeon's discretion.
At the surgeon's discretion, the procedure may be converted to a traditional TURBT utilizing either monopolar or bipolar loop electrocautery. Other intraoperative/postoperative decisions based on surgeon discretion and standard of care treatment:
Each specimen will be collected and sent en bloc to the pathology department. Ameer Hazma, MD, a genitourinary pathologist, will review all specimens to decrease interobserver variation.
Urinary symptoms before and after the procedure will be evaluated. This will be assessed via an electronic questionnaire that will be sent to study participants. Symptoms will be evaluated pre-operatively the morning of surgery as well as on post-operative day #3, 7, and 14.
No validated questionnaire for evaluation of urinary symptoms after bladder tumor resection currently exists. From clinical experience, the symptoms patients most commonly report include frequency, urgency, dysuria, or hematuria. The investigator will therefore modified the existing American Urological Association's Symptom score to address these symptoms on a shorter term basis.
A prospective data collection of the patients with bladder cancer undergoing en bloc resection will be conducted in this study.
A complete medical, surgical and bladder cancer history will be obtained by the surgical team in the pre-operative setting, per standard of care practices.
Patients will be taken to the operating room per standard of care for resection of one or more bladder tumors. The SOLTIVE™ Super Pulsed Thulium laser will be utilized for resection of the tumors in an en bloc fashion.
Technique for en bloc resection of bladder tumor Tumor marked with a circular coagulation blockage border approximately 1.0 cm away from the edge. All visible vessels around the tumor will be coagulated and lasered before the incision to reduce bleeding. Along this mark, a fan-shaped incision into the bladder wall is made until the muscle layer is visible uplift tumor by the force of the irrigation and use of the laser tip, gradually exposing the tumor base tumor base is disconnected tumor is then removed en bloc. If it is unable to be removed through the resectoscope in one piece due to its size, it may be cut into 2 pieces at the surgeon's discretion.
At the surgeon's discretion, the procedure may be converted to a traditional TURBT utilizing either monopolar or bipolar loop electrocautery. Other intraoperative/postoperative decisions based on surgeon discretion and standard of care treatment:
Each specimen will be collected and sent en bloc to the pathology department. Ameer Hazma, MD, a genitourinary pathologist, will review all specimens to decrease interobserver variation.
Urinary symptoms before and after the procedure will be evaluated. This will be assessed via an electronic questionnaire that will be sent to study participants. Symptoms will be evaluated pre-operatively the morning of surgery as well as on post-operative day #3, 7, and 14.
No validated questionnaire for evaluation of urinary symptoms after bladder tumor resection currently exists. From clinical experience, the symptoms patients most commonly report include frequency, urgency, dysuria, or hematuria. The investigator will therefore modified the existing American Urological Association's Symptom score to address these symptoms on a shorter term basis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: