Prospective Comparison Between Different Laser Settings f... | NCT02279927

Studies
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy

NCT02279927

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

Oct 31, 2014Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Ureterolithiasis
Nephrolithiasis

Interventions

Ureteroscopy

Countries

Israel

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

Oct 2014

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

Oct 2014

Primary Completion Date

Nov 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Oct 29, 2014

First Submission Date that Met QC Criteria

Oct 29, 2014

First Posted Date

Oct 31, 2014Estimated

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

Oct 29, 2014

Last Update Posted Date

Oct 31, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy

Detailed Description

Two groups prospectively randomized for different laser settings during ureteroscopy one aimed for stone dusting, the other for stone fragmentation and basket extraction of fragments

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low energy high frequency	Experimental	Ureteroscopy with laser settings of low energy & high frequency with aim of stone dusting	Device: Ureteroscopy
High energy low frequency	Active Comparator	Ureteroscopy with laser settings of low energy high frequency with aim of stone fragmentation and basket extraction of fragments	Device: Ureteroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ureteroscopy	Device	Ureteroscopy with laser stone fragmentation	High energy low frequency Low energy high frequency

Measure	Description	Time Frame
Stone free rate		1 month

Measure	Description	Time Frame
Duration of operation		Immediate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are planned for ureteroscopy \ retrograde intra renal surgery (RIRS) for stone treatment

Exclusion Criteria:

known ureteral stricture
severe immune deficiency
patients after urinary diversion surgery
patients with single \ ectopic\ implanted kidney
double collecting system
severe thrombocytopenia
patients taking anticoagulant drugs that cannot be stooped before the operation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuval Freifeld	Contact	+97248250843		yuvalfr@clalit.org.il

Overall Officials

Name	Affiliation	Role
Yuval Freifeld	Carmel MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center	Recruiting	Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D053039	Ureterolithiasis
D053040	Nephrolithiasis

Ancestor Terms

ID	Term
D014515	Ureteral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018666	Ureteroscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided