Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery

NCT ID: NCT02443909

Last Updated: 2015-05-14

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Nephrolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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first group

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

Group Type ACTIVE_COMPARATOR

Retrograde Intrarenal Surgery

Intervention Type PROCEDURE

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

Holmium laser device

Intervention Type DEVICE

second group

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

Group Type ACTIVE_COMPARATOR

Retrograde Intrarenal Surgery

Intervention Type PROCEDURE

Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)

Holmium laser device

Intervention Type DEVICE

third group

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

Group Type ACTIVE_COMPARATOR

Retrograde Intrarenal Surgery

Intervention Type PROCEDURE

Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)

Holmium laser device

Intervention Type DEVICE

Interventions

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Retrograde Intrarenal Surgery

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

Intervention Type PROCEDURE

Retrograde Intrarenal Surgery

Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)

Intervention Type PROCEDURE

Retrograde Intrarenal Surgery

Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)

Intervention Type PROCEDURE

Holmium laser device

Intervention Type DEVICE

Other Intervention Names

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RIRS RIRS RIRS

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients who have congenital urogenital abnormalities
* patients who have previous surgery history for urinary stones
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nihat Karakoyunlu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nihat Karakoyunlu, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Turkey

Locations

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S.B.Dıskapı Yıldırım Beyazıt Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nihat Karakoyunlu, MD

Role: CONTACT

00905324747134

Facility Contacts

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Nihat Karakoyunlu, MD

Role: primary

00905324747134

References

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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.

Reference Type RESULT
PMID: 25443519 (View on PubMed)

Other Identifiers

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26.01.2015

Identifier Type: -

Identifier Source: org_study_id

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