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New suction laser could zap kidney stones faster and safer

NCT ID NCT06667466

Disease control Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a new way to remove kidney stones using a special laser and a flexible suction sheath. 140 adults with stones between 6mm and 20mm will be randomly assigned to get the new suction sheath or a standard sheath. The goal is to see if the new method clears more stones and causes fewer complications.

What this could mean

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

Active substance
Super Pulsed Thulium Fiber Laser (sTFL) and Flexible Negative Pressure Ureteral Access Sheath
What this could lead to
If it works, this could offer a more effective and safer way to remove kidney stones, reducing the need for repeat procedures.
What could go wrong
This is a relatively small, early-stage trial. The new device may not prove significantly better than the standard sheath, and there are always risks of infection or injury during surgery.

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.

Participants

About 140 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

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.

Who is studied

Patients aged 18-70 years who plan to undergo ureteral soft endoscopic (fURS) lithotripsy for kidney stones and/or ureteral stones (6-20mm)

Ages

18 to 70 years

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 old. * Diagnosed with kidney stones and/or ureteral stones, and stone diameter is ≥6mm and ≤20mm * Plan to undergo fURS lithotripsy * General anesthesia to complete the operation * The latest urine culture before surgery is negative * Signed and dated informed consent Exclusion Criteria: * Isolated kidney * Previous history of kidney transplantation or urinary diversion surgery * Congenital malformations of urinary system * Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc * Severe heart or lung disease, malignancy and immune deficiency status * Neurogenic bladder * Failure to provide informed consent * Have an untreated urinary tract infection * The presence of known anatomic abnormalities (such as ureteral stenosis), urothelial tumors, or stones that can be removed directly without the use of laser lithotripsy * Pregnant women * In cases where the stone cannot be reached with a bendable negative pressure suction sheath, or in cases where the stone cannot be reached with a conventional sheath or the pyeloureteral junction * Epidural anesthesia or lumbar anesthesia to complete the operation

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis Ureteral Calculi ureterolithiasis

As listed by the trial registrant

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

Kidney calculi Ureteral calculi

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.