CompletedNot Applicable

Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

United States20 participantsStarted 2016-02

Plain-language summary

Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject will be older than 18 years of age
✓. Subject was diagnosed with renal calculi meeting the following criteria:
✓. Subject is a candidate for FURS procedure
✓. Subject is willing and has signed the Informed Consent Form

Exclusion criteria

✕. Subject has undergone a previous treatment for stones in the same kidney
✕. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
✕. Female subject is pregnant
✕. Concomitant anticoagulant medication that cannot be suspended during surgery

What they're measuring

Stone Clearance

Timeframe: Stone clearance based on 1 month follow-up imaging data

Post-procedure Catheterization

Timeframe: Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure

Procedure Time

Timeframe: during the procedure

Usage of Alternative Stone Extracting Devices

Timeframe: as measured during the procedure

Hospital Stay

Timeframe: Procedure through hospital discharge

Trial details

NCT IDNCT02683993

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-01-31

Results submitted2025-09-30

View on ClinicalTrials.gov More Stone Clearance trials