Clinical trial · Observational
LaserEn: SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
- description
- SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
- interventionNames
- Procedure: SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
Primary outcomes (1)
- measure
- To determine the ability to obtain identifiable pathologic characteristics of bladder tumor specimens by use the SOLTIVE™ laser during en bloc resection.
- timeFrame
- 6 months
- description
- To determine the ability to obtain identifiable pathologic characteristics of bladder tumor specimens by use the SOLTIVE™ laser during en bloc resection.
Secondary outcomes (3)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available