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Can watching and waiting beat surgery for silent kidney stones?

NCT ID NCT07718802

Disease control Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial compares two approaches for people with small, symptom-free kidney stones: immediate surgery versus simply monitoring them over time. Researchers want to know which strategy leads to less disruption in daily life, fewer emergency visits, and better overall well-being. The study includes both children and adults with stones measuring 4 to 10 millimeters that are not causing pain or blockage.

What this could mean

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

Active substance
surgery (ureteroscopy or shockwave lithotripsy) versus observation
What this could lead to
If observation proves as good as or better than surgery, many people with asymptomatic kidney stones could avoid unnecessary procedures.
What could go wrong
This is a large trial, but results may not apply to everyone with kidney stones. Observation carries a risk that stones may later cause symptoms or require emergency treatment.

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 1,658 people

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

Started

Aug 2026

Expected to finish

Oct 2032

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

6 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: 1. Individuals age 6 or older 2. Diagnosis of kidney stone disease (nephrolithiasis) 3. Asymptomatic, non-obstructive kidney stones measuring 4 to 10 mm (inclusive) * Asymptomatic is defined as the absence of abdominal pain, flank pain, gross hematuria, and nausea and/or vomiting in the last 3 months that in the judgement of the site PI could be attributable to kidney stones. * Non-obstructive is defined as a stone in a renal calyx or stones in multiple renal calyces on CT, ultrasound, and/or x-ray obtained within 6 months of screening. 4. Informed consent and if appropriate, child assent. 5. Willingness to be randomized to surgery or observation Note: subjects otherwise eligible who decline randomization may be enrolled in a parallel observational cohort. 6. Fluent in English or Spanish 7. Willingness to be audio- and/or video- recorded during interviews Exclusion Criteria: 1. Untreated hydronephrosis or caliectasis 2. Pain (e.g., renal colic, abdominal pain) or gross hematuria attributed to kidney stones. 3. Recurrent symptomatic urinary tract infections (≥3 in 12 months or ≥2 in 6 months). A symptomatic urinary tract infection is defined as having at least one bladder or voiding symptom (e.g., frequency, urgency, dysuria) with bacteriuria (≥105 colony forming units/mL of no more than 2 urinary tract pathogens). 4. Stone in the renal pelvis, ureter, bladder or urethra 5. Pregnant females 6. Solitary kidney, transplant kidney, urinary diversion, medullary sponge kidney 7. Anatomic abnormality of the kidney (e.g., horseshoe kidney) 8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis

As listed by the trial registrant

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

Kidney stone Nephrolithiasis

How to take part

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

  1. The places running it

    2 sites. 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

  • The Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Minnesota

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55454, United States

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