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NCT04979156: LaserEn
LaserEn: SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
trial testing SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors in Bladder Cancer in 20 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | University of Kansas Medical Center |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 4 November 2021 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
Conditions studied
- Bladder Cancer — all drugs for Bladder Cancer →
- Surgery — all drugs for Surgery →
Sponsor
University of Kansas Medical Center
Who can join
18 and older, any sex, with Bladder Cancer or Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04979156
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04979156 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Kansas Medical Center
- Last refreshed: 16 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04979156.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing