ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach

NCT ID: NCT06547632

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-12-01

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.

Conditions

Nephrolithiasis; Kidney Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH

In Arm 1, participants will undergo RIRS with ClearPetra™ vacuum-assisted ureteral access sheath.

Participants will undergo RIRS per standard of care.

Group Type: ACTIVE_COMPARATOR

ClearPetra Ureteral access sheath

Intervention Type: DEVICE

Patients will be randomly assigned (1:1) to vacuum-assisted (ClearPetra) or traditional approach group for retrograde intrarenal surgery according to standard of care.

2. RIRS WITH TRADITIONAL APPROACH

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®)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ClearPetra Ureteral access sheath

Patients will be randomly assigned (1:1) to vacuum-assisted (ClearPetra) or traditional approach group for retrograde intrarenal surgery according to standard of care.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wilson Molina

Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wilson Molina, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jane Ledesma

Role: CONTACT

jledesma2@kumc.edu

19135888721

Facility Contacts

Jane Ledesma, BS

Role: primary

jledesma2@kumc.edu

913-588-8721

References

Tonyali S. Suctioning ureteral access sheath use in flexible ureteroscopy might decrease operation time and prevent infectious complications. World J Urol. 2019 Feb;37(2):393-394. doi: 10.1007/s00345-018-2510-5. Epub 2018 Sep 26. No abstract available.

Reference Type: BACKGROUND

PMID: 30259124 (View on PubMed)

Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.

Reference Type: BACKGROUND

PMID: 27238616 (View on PubMed)

Chen Y, Zheng L, Lin L, Li C, Gao L, Ke L, Kuang R, Chen J. A novel flexible vacuum-assisted ureteric access sheath in retrograde intrarenal surgery. BJU Int. 2022 Nov;130(5):586-588. doi: 10.1111/bju.15873. Epub 2022 Sep 6. No abstract available.

Reference Type: BACKGROUND

PMID: 35986898 (View on PubMed)

Other Identifiers

STUDY00161273

Identifier Type: -

Identifier Source: org_study_id