Thulium Fiber Laser Prospective Trial

NCT ID: NCT05814133

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2025-07-15

Brief Summary

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This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.

Detailed Description

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Flexible ureteroscopy is considered the first-line therapy for renal stones \< 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.

Conditions

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Kidney Stone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lithotripsy

Ureteroscopy with lithotripsy using the Thulium Fiber Laser

Group Type EXPERIMENTAL

Thulium Fiber Laser

Intervention Type DEVICE

Thulium Fiber Laser will be used to break renal stones \< 2 cm into fragments small enough to remove or pass spontaneously through the ureter.

Interventions

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Thulium Fiber Laser

Thulium Fiber Laser will be used to break renal stones \< 2 cm into fragments small enough to remove or pass spontaneously through the ureter.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required
* Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
* Must be 18 years or older
* Must be able to give consent
* Bilateral ureteroscopy will be permitted but only the first side will be included in the study

Exclusion Criteria

* Concomitant stones in the ureter
* Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
* Prior radiotherapy to the abdomen or pelvis
* Neurogenic bladder or spinal cord injury
* Pregnancy
* Untreated Urinary Tract Infection (UTI)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naeem Bhojani, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

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Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Naeem Bhojani, M.D

Role: CONTACT

5148908000 ext. 22931

Kahina Bensaadi, DESS

Role: CONTACT

5148908000 ext. 30824

Facility Contacts

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Naeem Bhojani, MD

Role: primary

Kahina Bensaadi

Role: backup

References

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Kronenberg P, Traxer O. Update on lasers in urology 2014: current assessment on holmium:yttrium-aluminum-garnet (Ho:YAG) laser lithotripter settings and laser fibers. World J Urol. 2015 Apr;33(4):463-9. doi: 10.1007/s00345-014-1395-1. Epub 2014 Sep 4.

Reference Type BACKGROUND
PMID: 25185524 (View on PubMed)

Nazif OA, Teichman JM, Glickman RD, Welch AJ. Review of laser fibers: a practical guide for urologists. J Endourol. 2004 Nov;18(9):818-29. doi: 10.1089/end.2004.18.818.

Reference Type BACKGROUND
PMID: 15659912 (View on PubMed)

Khusid JA, Khargi R, Seiden B, Sadiq AS, Atallah WM, Gupta M. Thulium fiber laser utilization in urological surgery: A narrative review. Investig Clin Urol. 2021 Mar;62(2):136-147. doi: 10.4111/icu.20200467.

Reference Type BACKGROUND
PMID: 33660440 (View on PubMed)

Kronenberg P, Hameed BZ, Somani B. Outcomes of thulium fibre laser for treatment of urinary tract stones: results of a systematic review. Curr Opin Urol. 2021 Mar 1;31(2):80-86. doi: 10.1097/MOU.0000000000000853.

Reference Type BACKGROUND
PMID: 33470684 (View on PubMed)

Traxer O, Corrales M. Managing Urolithiasis with Thulium Fiber Laser: Updated Real-Life Results-A Systematic Review. J Clin Med. 2021 Jul 30;10(15):3390. doi: 10.3390/jcm10153390.

Reference Type BACKGROUND
PMID: 34362169 (View on PubMed)

Law KE, Lowndes BR, Kelley SR, Blocker RC, Larson DW, Hallbeck MS, Nelson H. NASA-Task Load Index Differentiates Surgical Approach: Opportunities for Improvement in Colon and Rectal Surgery. Ann Surg. 2020 May;271(5):906-912. doi: 10.1097/SLA.0000000000003173.

Reference Type BACKGROUND
PMID: 30614878 (View on PubMed)

Related Links

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http://www.urotoday.com/conference-highlights/aua-2019-annual-meeting/aua-2019-stone-disease/112422-aua-2019-comparison-of-dusting-and-fragmenting-using-the-new-super-pulse-thulium-fiber-laser-to-a-120w-holmium-yag-laser.html

Chew \* Ben H., Knudsen BE, Molina WR. Mp79-19 comparison of dusting and fragmenting using the new super pulse thulium fiber laser to a 120w holmium:yag laser. Journal of Urology. 2019 Apr;201(Supplement 4):e1159-60.

Other Identifiers

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2023-11370

Identifier Type: -

Identifier Source: org_study_id

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