Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Nephrology, Nephrology, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/30/2017 |
| Start Date: | February 2016 |
| End Date: | September 2017 |
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.
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.
Inclusion Criteria:
1. Subject will be older than 18 years of age
2. Subject was diagnosed with renal calculi meeting the following criteria:
- Largest stone measures no more than 2cm on a single diameter and is no less than
0.8cm as defined by X-ray or CT.
- Accumulative stone burden (addition of all stone diameters) is no more than
2.5cm.
3. Subject is a candidate for FURS procedure
4. Subject is willing and has signed the Informed Consent Form
Exclusion Criteria:
1. Subject has undergone a previous treatment for stones in the same kidney
2. Subject requires another, concomitant procedure, other than FURS, to be performed
during this treatment session.
3. Female subject is pregnant
4. Concomitant anticoagulant medication that cannot be suspended during surgery
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