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Vacuum-Assisted sheath aims to clear kidney stones faster

NCT ID NCT07678255

Disease control Sponsor: Hospitales Universitarios Virgen del Rocío Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial tests whether a vacuum-assisted ureteral access sheath (ClearPetra) removes kidney stones more completely than a standard rigid sheath (Navigator) during flexible ureteroscopy. About 156 adults with stones 1-3 cm will be randomly assigned to one sheath. The main goal is to see if ClearPetra leads to a higher stone-free rate at one month, with fewer repeat treatments and similar safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ClearPetra ureteral access sheath (vacuum-assisted) vs Navigator ureteral access sheath (standard rigid)
What this could lead to
If the vacuum-assisted sheath works better, it could mean fewer repeat procedures and shorter surgeries for people with kidney stones.
What could go wrong
This is a single-center trial with 156 participants, so results may not apply broadly. The new sheath might not improve stone clearance or could have unexpected complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * Diagnosis of intrarenal lithiasis with maximum stone diameter of 1-3 cm on preoperative non-contrast abdomino-pelvic CT scan * Candidate for treatment by flexible ureteroscopy (RIRS) as indicated by the treating urologist * Attended at the Department of Urology, Hospital Universitario Virgen del Rocío (Seville, Spain) * Willing and able to provide written informed consent * Able to comply with the study follow-up schedule (CT scan at 1 and 3 months post-intervention) Exclusion Criteria: * Active urinary tract infection or urosepsis at the time of the planned intervention * Known ureteral stricture precluding passage of a ureteral access sheath * Pregnancy * Prior urinary diversion incompatible with transurethral access (e.g., urinary conduit, neobladder) * Bleeding disorder or anticoagulant/antiplatelet therapy that cannot be safely interrupted perioperatively * Stone diameter \<1 cm or \>3 cm on preoperative CT * Inability to provide informed consent (cognitive impairment, language barrier without interpreter availability) * Simultaneous participation in another clinical trial that could interfere with the outcomes of this study

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis urolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney calculi Nephrolithiasis Ureteroscopy Urolithiasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Virgen del Rocio University Hospital

    Seville, Seville, 41013, Spain

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