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NCT06320860 Clinical Trial

FlexStone Enabled Kidney Stone Retrieval

Kidney Calculi Clinical Trial

Official title:
FlexStone Enabled Kidney Stone Retrieval

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06320860
Other study ID # IRB231189
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 8, 2024
Est. completion date September 8, 2024

Study information
Verified date March 2024
Source EndoTheia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 10
Est. completion date September 8, 2024
Est. primary completion date September 8, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Kidney Stone Retrieval
Using FlexStone Basket aimability to retrieve kidney stones

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
EndoTheia Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Day 1 Post-Intervention
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