FlexStone Enabled Kidney Stone Retrieval

N/ACompletedNCT06320860

EndoTheia10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Kidney Calculi

Interventions

Kidney Stone RetrievalDEVICE

Using FlexStone Basket aimability to retrieve kidney stones

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Successful retrieval of kidney stones

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.

Time frame: Day 1 Post-Intervention

Data from ClinicalTrials.gov

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