NCT02279927

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

October 29, 2014

Last Update Submit

October 29, 2014

Conditions

UreterolithiasisNephrolithiasis

Keywords

Ureteroscopy

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    1 month

Secondary Outcomes (1)

  • Duration of operation

    Immediate

Study Arms (2)

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

UreteroscopyDEVICE

Ureteroscopy with laser stone fragmentation

High energy low frequencyLow energy high frequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

UreterolithiasisNephrolithiasis

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesKidney Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Yuval Freifeld

    Carmel MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Freifeld

CONTACT

+97248250843yuvalfr@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations

IL(1)