NephrolithiasisOASISNCT07718802
Observational Approach Versus Surgical Intervention for Stones
A study testing Surgery and Observation in people with Nephrolithiasis and Kidney Stone, run by Children's Hospital of Philadelphia at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Nephrolithiasis, Kidney Stone
- What is being tested?
- Surgery and Observation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,658 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Aug 2026to 1 Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals age 6 or older
- Diagnosis of kidney stone disease (nephrolithiasis)
- 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.
- Informed consent and if appropriate, child assent.
Show all 9Show fewer
- Willingness to be randomized to surgery or observation Note: subjects otherwise eligible who decline randomization may be enrolled in a parallel observational cohort.
- Fluent in English or Spanish
- Willingness to be audio- and/or video- recorded during interviews
Who cannot join
- Untreated hydronephrosis or caliectasis
- Pain (e.g., renal colic, abdominal pain) or gross hematuria attributed to kidney stones.
- 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).
- Stone in the renal pelvis, ureter, bladder or urethra
- Pregnant females
- Solitary kidney, transplant kidney, urinary diversion, medullary sponge kidney
- Anatomic abnormality of the kidney (e.g., horseshoe kidney)
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
The Children's Hospital of Philadelphia
Hatboro, Pennsylvania, 19040
Rebecca D McCune, BS, MS, 267-909-6030, mccuner@chop.edu
Brian Augelli, BS, 609-504-4908, augellib@chop.edu
- Recruiting
University of California, Irvine
Irvine, California, 92612
Ryan Hsi, MD, 657-579-4535, rhsi1@hs.uci.edu
Roshan Patel, MD
- Not yet recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Vishnuvardhan Ganesan, MD, 612-625-7486, ganes119@umn.edu
Judith Graziano, RN, PhD, (612) 625-2667, grazi005@umn.edu
- Not yet recruiting
Columbia University Medical Center
New York, New York, 10032
OJas Shah, MD, 212-342-6059, os2302@cumc.columbia.edu
Ezra Margolin, MD
About this study
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.
Read the detailed description
A critical barrier to improving the health of the nearly 40 million Americans with kidney stone disease is the weak evidence base supporting the management of individuals with asymptomatic kidney stones. The proposed Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) randomized clinical trial answers the research question of whether observation or upfront surgery results in less life disruption from asymptomatic kidney stones for children and adults. The management options for patients with asymptomatic stones are 1) observation or 2) upfront surgical treatment, both of which are considered safe, part of usual care, widely accessible, and covered by insurance.
OASIS responds to the charge for well-designed Randomized Controlled Trials (RCT) from the Agency for Healthcare Research and Quality (AHRQ) systematic review on kidney stone disease management and ensures patient centeredness by examining outcomes that patients have identified as meaningful.
Intervention
Randomization to either:
- Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
- Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy (URS) and shockwave lithotripsy (SWL), which are routinely used in standard clinical care.
Observational Cohort (Non-Randomized Cohort):
Up to 300 eligible subjects who are willing to consent to data collection but refuse randomization will be enrolled and followed for two years.
Study Design OASIS is a pragmatic randomized controlled superiority trial conducted at approximately 30 sites that participate in Patient Centered Outcomes Research Network (PCORnet). The trial will include an additional observational cohort for eligible subjects who decline randomization.
- Conditions
- Nephrolithiasis, Kidney Stone
- Being tested
- Surgery, Observation
- Keywords
- kidney stones, kidney, nephrolithiasis, Comparative Effectiveness, Patient Reported Outcomes
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
ObservationOther
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Non-Randomized (Observational) | Active comparator | Not described Receives: Procedure: Surgery; Other: Observation |
| Randomized | Active comparator | Not described Receives: Procedure: Surgery; Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare-related life disruption
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.
Measured: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Secondary outcomes (7)
Patient reported physical and emotional health (Pain Interference)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) is a standardized, self-reported assessment tool developed by the National Institutes of Health (NIH). It measures how much pain hinders a person's physical, mental, social, and recreational activities, as well as their sleep and enjoyment of life. It uses a standardized T-score (average is 50; standard deviation is 10) to reflect the level of disruption. Higher numbers mean more pain interference (pain is having a greater negative impact on your daily life, making it harder to participate in work, social, and physical activities). The study team is using the validated versions for adults (18 years and older at time of consent), children (ages 8-17 years at time of consent), and parent-proxy versions for caregivers of children ages (6-7 years at time of consent). This information will be captured via patient report in REDCap.
Measured: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient reported physical and emotional health (Anxiety)
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety is a standardized, self-reported assessment tool developed by the National Institutes of Health (NIH). It measures the severity of fear, worry, dread, hyperarousal, and physical stress symptoms over the past seven days on a 5-point scale (ranging from never to always). Raw scores are converted into a standardized T-score with an average of 50 and a standard deviation of 10. A higher T-score indicates a higher severity of anxiety. The study team is using validated versions for adults (18 years and older at time of consent), children (ages 8-17 years at time of consent), and parent-proxy versions for caregivers of children ages (6-7 years at time of consent). This information will be captured via patient report in REDCap.
Measured: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient reported physical and emotional health (Stone Quality of Life)
The Wisconsin Stone Quality of Life questionnaire (WISQOL) is a disease-specific health-related quality of life (HRQOL) instrument designed to assess the impact on patients of stones in the urinary tract. Each item is scored on a 5-point Likert scale, yielding a total raw score of 28 to 140. Higher scores reflect a better health-related quality of life. Raw scores are typically converted to a standardized 0-100 scale. This information will be captured via patient report on REDCap.
Measured: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Stone passage
Patient Reported Survey: Number of self-reported stone passages (A kidney stone episode is passing a stone that caused pain or other bothersome symptoms or having surgery to remove a stone.) This information will be captured via patient report on REDCap.
Measured: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months. Reporting total after 2 years.
Lost productivity (Missed School)
Patient Reported Survey: Number of days the patient (for patients under 18 years old at time of consent) missed school due to kidney stones or kidney stone-related care (0 days, 1-2 days, 3-5 days, 6-10 days, more than 10 days) in the last 3 months. This information will be captured via patient report in REDCap.
Measured: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Lost productivity (Caregiver Missed Work)
Patient Reported Survey: Number of days the patient's caregiver(s) (for patients <18 years old at time of consent) missed work due to kidney stones or kidney stone-related care (0 days, 1-2 days, 3-5 days, 6-10 days, more than 10 days) in the last 3 months. This information will be captured via patient report on REDCap.
Measured: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Lost productivity (Patient Missed Work)
Patient Reported Survey: Number of days the patient missed work (for patients 18 years and older at time of consent) due to kidney stones or kidney stone-related care (0 days, 1-2 days, 3-5 days, 6-10 days, More than 10 days) in the last 3 months. This information will be captured via patient report in REDCap.
Measured: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start17 Aug 2026
- Primary completion31 May 2031 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Gregory E Tasian, MD, MSc, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718802
- Sponsor's protocol ID
- 26-024242
- Other IDs
- BPS-2025C1-44653
- Acronym
- OASIS
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Approach Versus Surgical Intervention for Stones
- ClinicalTrials.gov ID
- NCT07718802
- Acronym / sponsor ID
- OASIS / 26-024242
- Conditions
- Nephrolithiasis, Kidney Stone
- Keywords
- kidney stones, kidney, nephrolithiasis, Comparative Effectiveness, Patient Reported Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,658 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A critical barrier to improving the health of the nearly 40 million Americans with kidney stone disease is the weak evidence base supporting the management of individuals with asymptomatic kidney stones. The proposed Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) randomized clinical trial answers the research question of whether observation or upfront surgery results in less life disruption from asymptomatic kidney stones for children and adults. The management options for patients with asymptomatic stones are 1) observation or 2) upfront surgical treatment, both of which are considered safe, part of usual care, widely accessible, and covered by insurance.
OASIS responds to the charge for well-designed Randomized Controlled Trials (RCT) from the Agency for Healthcare Research and Quality (AHRQ) systematic review on kidney stone disease management and ensures patient centeredness by examining outcomes that patients have identified as meaningful.
Intervention
Randomization to either:
- Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
- Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy (URS) and shockwave lithotripsy (SWL), which are routinely used in standard clinical care.
Observational Cohort (Non-Randomized Cohort):
Up to 300 eligible subjects who are willing to consent to data collection but refuse randomization will be enrolled and followed for two years.
Study Design OASIS is a pragmatic randomized controlled superiority trial conducted at approximately 30 sites that participate in Patient Centered Outcomes Research Network (PCORnet). The trial will include an additional observational cohort for eligible subjects who decline randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Randomized (Observational) | Active comparator | Procedure: Surgery, Other: Observation |
| Randomized | Active comparator | Procedure: Surgery, Other: Observation |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals age 6 or older
- Diagnosis of kidney stone disease (nephrolithiasis)
- Asymptomatic, non-obstructive kidney stones measuring 4 to 10 mm (inclusive)
- Informed consent and if appropriate, child assent.
- Willingness to be randomized to surgery or observation Note: subjects otherwise eligible who decline randomization may be enrolled in a parallel observational cohort.
Key exclusion criteria (8 listed)
- Untreated hydronephrosis or caliectasis
- Pain (e.g., renal colic, abdominal pain) or gross hematuria attributed to kidney stones.
- 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).
- Stone in the renal pelvis, ureter, bladder or urethra
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryUpfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care. | Procedure or surgery | Non-Randomized (Observational), Randomized |
| ObservationObservation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits. | Other | Non-Randomized (Observational), Randomized |
Primary outcome
Healthcare-related life disruption
Time frame: Every 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.
7 secondary outcomes
Patient reported physical and emotional health (Pain Interference)
Time frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient reported physical and emotional health (Anxiety)
Time frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient reported physical and emotional health (Stone Quality of Life)
Time frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Stone passage
Time frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months. Reporting total after 2 years.
Lost productivity (Missed School)
Time frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Lost productivity (Caregiver Missed Work)
Time frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Lost productivity (Patient Missed Work)
Time frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory E Tasian, MD, MSc, MSCE principal investigator
Children's Hospital of Philadelphia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Observation in people with Nephrolithiasis and Kidney Stone, run by Children's Hospital of Philadelphia at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca D McCune, BS, MS (267-909-6030, mccuner@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.