FlexStone Enabled Kidney Stone Retrieval

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

Completed

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Key information

Conditions

Kidney Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kidney Stone Retrieval

Device

Using FlexStone Basket aimability to retrieve kidney stones

Primary outcomes

Successful retrieval of kidney stones

Time frame: Day 1 Post-Intervention

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.

Sponsors and collaborators

Lead sponsor

EndoTheia

Industry

Collaborators

Vanderbilt University Medical Center

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Mar 20, 2024
Registry last updated: Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed