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
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

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