ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach

NCT06547632 | Terminated FDA Device

• 1 other identifier: STUDY00161273
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone; Nephrolithiasis

Keywords

Nephrolithiasis; Kidney Stone; ClearPetra; Ureteral access sheath

Outcome Measures

Primary Outcomes (1)

• Stone Free Status between ClearPetra and traditional approach

  Stone free is defined as no residual stones \>2mm in post operative CT scan

  90 days

Secondary Outcomes (2)

• Total operative time between ClearPetra and traditional approach

  1 day

• Urinary tract infection between ClearPetra and traditional approach

  30 days of procedure

Study Arms (2)

1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH

ACTIVE COMPARATOR

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

Device: ClearPetra Ureteral access sheath

2. RIRS WITH TRADITIONAL APPROACH

NO INTERVENTION

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®)

Interventions

ClearPetra Ureteral access sheath 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.

1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females over18 years of age
• Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
• Total stone burden between 1.0 to 2.5 cm

You may not qualify if:

• Undergoing bilateral stone treatment during the same procedure
• Patients with known genitourinary anatomical abnormalities
• Uncorrected coagulopathy
• Patients with urinary diversions
• Chronic external urinary catheters
• Women who are pregnant
• Immunosuppressed patients
• Non-elective procedures

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (3)

• 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.

  PMID: 30259124 BACKGROUND

• 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.

  PMID: 27238616 BACKGROUND

• 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.

  PMID: 35986898 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilson Molina, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Model Details: Parallel assignment

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: July 31, 2025
• Primary Completion: January 21, 2026
• Study Completion: February 27, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)