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Observational Approach Versus Surgical Intervention for Kidney Stones (OASIS)

This study, called OASIS, is looking at the best way to manage kidney stones (nephrolithiasis) that aren't causing symptoms. It compares two approaches: observation, which involves regular check-ups and scans (CT, ultrasound, or X-ray), and upfront surgery, which includes common procedures like ureteroscopy and shockwave lithotripsy to remove the stones. The main goal is to see which approach causes less disruption to your daily life. You might be able to join if you are 6 years or older, have kidney stones between 4 and 10 mm, and they aren't causing you any pain or other symptoms. The study aims to enroll 1658 people.

Study design
This is an interventional study that will compare two treatment approaches. It plans to enroll 1658 participants.
What's involved
If you join, you would either have regular check-ups and scans every 3 months for up to 24 months, or undergo surgery to remove your kidney stones.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months to measure healthcare-related life disruption.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07718802

Observational Approach Versus Surgical Intervention for Stones

Not Yet Recruiting
NAAges 6+InterventionalTreatment
Children's Hospital of Philadelphia
~1,658 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:SurgeryObservation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Healthcare-related life disruption
Measured over Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

Conditions

Nephrolithiasis
Kidney Stone

Explore related trials

Nephrolithiasis

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Gregory E Tasian, MD, MSc, MSCE · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Rebecca D McCune, BS, MS
[email protected]
267-909-6030
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Healthcare-related life disruptionEvery 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

    Composite of: Stone-specific emergency department (ED)/urgent care visits, stone-specific hospitalizations and surgery for stones for new symptoms (Shockwave Lithotripsy (SWL) and Ureteroscopy (URS)) as reported via Patient Centered Outcomes Research Network (PCORnet) Common Data Model (CDM) query and participant self-report on REDCap.