Kidney Calculi
Conditions
Brief summary
This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets.
Detailed description
The clinical practice at Vanderbilt University Medical Center will perform standard flexible ureteroscopy (fURS) procedures using conventional stone retrieval baskets, the EndoTheia FlexStone basket, laser fibers for intracorporeal lithotripsy , and any other fURS accessory devices as determined by the surgeon. If renal calculi are present which the physician deems retrieval of would benefit from the added aimability of the EndoTheia FlexStone basket will be used.
Interventions
DEVICEKidney Stone Retrieval
Using FlexStone Basket aimability to retrieve kidney stones
Sponsors
Vanderbilt University Medical Center
EndoTheia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 to 80 years of age * Able to provide written informed consent * Have renal stones present and are appropriate candidates for fURS
Exclusion criteria
* Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing. * Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer. * Patients with active urinary tract infection or anatomy that complicates retrograde access to the ureter and kidney * Patients who do not meet inclusion criteria * Patients who are unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful retrieval of kidney stones | Day 1 Post-Intervention | The primary end point of this feasibility study is to demonstrate that the additional basket aimability of the device enables basket to capture stones in difficult to reach locations such as the lower pole. |
Countries
United States
Outcome results
None listed