Kidney Stone, Nephrolithiasis
Conditions
Keywords
Nephrolithiasis, Kidney Stone, ClearPetra, Ureteral access sheath
Brief summary
Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm. This procedure is usually performed together with ureteral access sheaths, which helps protect the ureter mucosa and lowers intrarenal pressure. Recently, a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration. Because there is little information on comparing this device with traditional approach (no sheath or non-vacuum-assisted sheath) in American population, we aim to compare those devices in terms of their ability to clear the kidney from kidney stones, as well as reduce infection rates postoperatively.
Detailed description
Retrograde intrarenal surgery (RIRS) is now considered gold-standard for treatment of renal stones smaller than 2 cm. This procedure often employs a ureteral access sheath (UAS), as it helps to reduce intrarenal pressure and protects the ureter mucosa when basketing is required. However, the challenge imposed by residual stone fragments and sepsis remains. Additionally, natural elimination of residual stone fragments may induce renal colic, hematuria an even the potential for new stone development. Recently, a new vacuum-assisted ureteral access sheath (VA-UAS) named ClearPetra™ provides concomitant stone fragmentation and aspiration. The new ClearPetra™ vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones. It is a disposable access sheath equipped with a continuous flow aspiration mechanism. Previous studies have demonstrated the safety and effectiveness of ClearPetra™ in RIRS Comprehensive comparative investigations between ClearPetra™ and traditional UAS in RIRS are lacking in American population. We aim to compare the outcomes of using VA-UAS (ClearPetra™) or traditional approach (no sheath or non-vacuum-assisted sheath) to treat patients with stone burden between 1.0 - 2.5 cm.
Interventions
Patients will be randomly assigned (1:1) to vacuum-assisted (ClearPetra) or traditional approach group for retrograde intrarenal surgery according to standard of care.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males or females over18 years of age 2. Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery 3. Total stone burden between 1.0 to 2.5 cm
Exclusion criteria
1. Undergoing bilateral stone treatment during the same procedure 2. Patients with known genitourinary anatomical abnormalities 3. Uncorrected coagulopathy 4. Patients with urinary diversions 5. Chronic external urinary catheters 6. Women who are pregnant 7. Immunosuppressed patients 8. Non-elective procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Free Status between ClearPetra and traditional approach | 90 days | Stone free is defined as no residual stones \>2mm in post operative CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total operative time between ClearPetra and traditional approach | 1 day | Time from scope insertion to scope removal from the patient |
| Urinary tract infection between ClearPetra and traditional approach | 30 days of procedure | Data collection searching for urine tract infection signs, symptoms, antibiotic administration and culture |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilson Molina, MD
Study Principal Investigator
Outcome results
None listed