FlexStone Enabled Kidney Stone Retrieval

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-08

Study Completion Date

2024-10-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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Kidney Calculi

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Kidney Stone Retrieval

All patients in this group will have the EndoTheia FlexStone basket used to assist in the retrieval of kidney stones

Group Type EXPERIMENTAL

Kidney Stone Retrieval

Intervention Type DEVICE

Using FlexStone Basket aimability to retrieve kidney stones

Interventions

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Kidney Stone Retrieval

Using FlexStone Basket aimability to retrieve kidney stones

Intervention Type DEVICE

Eligibility Criteria

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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

* Patients who are unable or unwilling to provide informed consent

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No