Purpose of this Study
In this study, people will be placed into one of two groups by chance. One group will have a procedure to remove the kidney stone within about 90 days of joining the study. The other group will be closely monitored without having the stone removed right away.
Everyone in the study will be followed for two years. Participants will have regular clinic visits, at least once each year, and will complete surveys every three months about any symptoms they have. Researchers want to learn which approach is better for people who have kidney stones that are not causing pain or other problems.
Who Can Participate?
Eligibility
Children who are at least 6 years old or adults of any age that have a stone in the kidney. The kidney stones should not be causing pain and not blocking the kidney. The stone must be seen on an ultrasound, x-ray, or CT scan in the past 6 months.
Age Range
6-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of the OASIS study is to learn which of two common approaches is better for people who have kidney stones that are not causing pain or other symptoms. One approach is to watch the stones closely over time. The other approach is to remove the stones before they cause problems.
Researchers do not yet know which option leads to the best results for patients. By comparing these two approaches, the study will help doctors learn whether it is better to remove symptom free kidney stones or monitor them carefully.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
Observational Approach versus Surgical Intervention for Stones (OASIS)
Principal Investigator
Charles
Scales
Protocol Number
PRO00120732
Enrollment Status
Pending Open to Enrollment