NCT02443909

Brief Summary

To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).

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
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

April 28, 2015

Last Update Submit

May 13, 2015

Conditions

Nephrolithiasis

Keywords

Holmium LaserKidney StonesRIRS

Outcome Measures

Primary Outcomes (2)

  • Safety (Complications according to clavien system)

    Complications according to clavien system

    1 day

  • Efficiency (visual analog score)

    visual analog score

    1 Day

Secondary Outcomes (1)

  • Efficiency (stone free rate)

    3 month

Study Arms (3)

first group

ACTIVE COMPARATOR

Patients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones

Procedure: Retrograde Intrarenal SurgeryDevice: Holmium laser device

second group

ACTIVE COMPARATOR

Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones

Procedure: Retrograde Intrarenal SurgeryDevice: Holmium laser device

third group

ACTIVE COMPARATOR

Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston

Procedure: Retrograde Intrarenal SurgeryDevice: Holmium laser device

Interventions

Retrograde Intrarenal SurgeryPROCEDURE

endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device

Also known as: RIRS
first group
Holmium laser deviceDEVICE
first groupsecond groupthird group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have 2-3 cm kidney stones
  • patients who are between 18-90 years old

You may not qualify if:

  • patients who have congenital urogenital abnormalities
  • patients who have previous surgery history for urinary stones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.B.Dıskapı Yıldırım Beyazıt Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Redondo C, Ramon de Fata F, Gimbernat H, Meilan E, Andres G, Angulo JC. Retrograde intrarenal surgery with holmium-YAG laser lithotripsy in the primary treatment of renal lithiasis. Actas Urol Esp. 2015 Jun;39(5):320-6. doi: 10.1016/j.acuro.2014.06.004. Epub 2014 Oct 25. English, Spanish.

    PMID: 25443519RESULT

MeSH Terms

Conditions

NephrolithiasisKidney Calculi

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Nihat Karakoyunlu, MD

    Ministry of Health, Turkey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nihat Karakoyunlu, MD

CONTACT

00905324747134nkarakoyunlu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 14, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

TU(1)