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ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach

Sponsored by University of Kansas Medical Center

About this trial

Last updated 5 months ago

Study ID

STUDY00161273

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Ended 5 months ago

What is this trial about?

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.

What are the participation requirements?

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