FlexStone Enabled Kidney Stone Retrieval

EndoTheia

Status

Completed

Conditions

Kidney Calculi

Treatments

Device: Kidney Stone Retrieval

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06320860

IRB231189

Details and patient eligibility

About

This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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