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Observational Approach Versus Surgical Intervention for Stones

NCT07718802 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1658

Last updated 2026-07-22

No results posted yet for this study

Summary

The aims of the Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) trial are: 1) to determine whether observation compared to upfront surgery results in less healthcare-related life disruption due to kidney stones among children and adults with asymptomatic kidney stones; 2) to identify the groups benefiting the most from each strategy; and 3) to determine the preferences and values informing the choice between observation and upfront surgery.

Conditions

  • Nephrolithiasis
  • Kidney Stone

Interventions

PROCEDURE

Surgery

Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.

OTHER

Observation

Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2031-05-31
Completion
2032-10-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718802 on ClinicalTrials.gov