Observational Approach Versus Surgical Intervention for Stones

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT07718802
Status
Recruiting
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Conditions

  • Kidney Stone
  • Nephrolithiasis

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgery — PROCEDURE
    Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
  • Observation — OTHER
    Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Aug 17, 2026
Status verified
Sep 2026
Primary completion
May 31, 2031
Completion
Oct 1, 2032

Study Design

Enrollment
1,658 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Non-Randomized (Observational)
  • Active Comparator: Randomized

Primary Outcome Measure

Healthcare-related life disruption [ Time Frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55454
Vishnuvardhan Ganesan, MD
[email protected]
612-625-7486
Judith Graziano, RN, PhD
[email protected]
(612) 625-2667
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Gregory E Tasian, MD, MSc, MSCE (PRINCIPAL_INVESTIGATOR)

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By research site
University of Minnesota· Minneapolis, MNThe Children's Hospital of Philadelphia· Philadelphia, PA

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