ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach (VA-UAS vs trad)

University of Kansas

Status: Not yet enrolling

Conditions: Kidney Stone; Nephrolithiasis

Treatments: Device: ClearPetra Ureteral access sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT06547632

STUDY00160906

Details and patient eligibility

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH

Active Comparator group

Description:

In Arm 1, participants will undergo RIRS with ClearPetra™ vacuum-assisted ureteral access sheath. Participants will undergo RIRS per standard of care.

Treatment:

Device: ClearPetra Ureteral access sheath

2. RIRS WITH TRADITIONAL APPROACH

No Intervention group

Description:

In Arm 2, participants will undergo RIRS a traditional approach (no sheath or non-vacuum-assisted sheath). The treating investigator will decide whether to use a regular UAS based on their preference and/or availability. * No ureteral access sheath * Navigator™ Ureteral Access Sheath 11/13 Fr (Boston Scientific®) * Navigator™ Ureteral Access Sheath 12/14 Fr (Boston Scientific®)