Thulium Fiber Laser vs. Holmium:YAG Laser for the Uretero... | NCT06306222

Studies
Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease

NCT06306222

Sponsor

IRCCS San Raffaele

Status

Unknown status

Last Update Posted

Mar 12, 2024Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Kidney Stone
Ureteral Stone

Interventions

Laser lithotripsy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 23, 2023Actual

Primary Completion Date

Nov 23, 2025Estimated

Completion Date

Feb 23, 2026Estimated

First Submitted Date

Dec 29, 2023

First Submission Date that Met QC Criteria

Mar 5, 2024

First Posted Date

Mar 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thulium fiber laser (TFL) lithotripsy	Experimental	Lithotripsy with TFL is a recently introduced procedure, that will be tested in this study.	Device: Laser lithotripsy
Holmium:YAG laser lithotripsy	Active Comparator	Holmium:YAG laser lithotripsy represents the gold standard for this procedure since 30 years.	Device: Laser lithotripsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser lithotripsy	Device	Ureteroscopic laser lithotripsy	Holmium:YAG laser lithotripsy Thulium fiber laser (TFL) lithotripsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lithotripsy speed		Through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Stone free rate		3 months after the procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Renal/ureteral stones > 4 mm

Exclusion Criteria:

Anatomical abnormalities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
D'Arma Alessia	Contact	+390226435506		darma.alessia@hsr.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Ospedale San Raffaele	Recruiting	Milan			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D053039	Ureterolithiasis

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017602	Lithotripsy, Laser

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D008096	Lithotripsy
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided