Recruiting

Miniaturized PCNL & Conventional Sheaths

Sponsor:

The Cleveland Clinic

Code:

NCT05993546

Conditions

Kidney Stone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

vacuum assisted sheath

passive suction via conventional sheath

Study Details

Brief summary:

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Conditions

Kidney Stone

Study ID

NCT05993546

Start date

Aug 29, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with planned prone mini-PCNL and a preoperative NCCT
  • Primary stone size: 10-25 mm
  • Pre-existing indwelling nephrostomy tube or ureteral stent permitted
  • Age: ≥ 18 years old
  • Gender: all
  • Ethnicity: all
  • Capable of giving informed consent
  • Capable and willing to fulfill requirements of the study

Exclusion Criteria:

  • Anticoagulated or history of coagulopathy
  • Congenital renal anomalies
  • Prior ipsilateral upper urinary tract reconstructive procedures
  • Conversion to open procedure
  • Multiple access tracts
  • Inability to give informed consent or unable to meet requirements of the study for any reason

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: vacuum-assisted sheath

active comparator: passive suction via conventional sheath

Interventions

vacuum assisted sheath

allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval

passive suction via conventional sheath

conventional access sheath for stone retrieval using current technique via passive suction

Primary outcome measure

  • Aim 1: Stone free rate [ Time Frame: 6 weeks ]
  • Aim 2: Intraoperative variables [ Time Frame: 3-7 days ]
  • Aim 3: Post-operative Outcomes and Complications [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Lauren Grimm

216-444-4650grimml@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Lauren Grimm

216-444-4650grimml@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-29.