FlexStone Enabled Kidney Stone Retrieval

March 13, 2024 updated by: EndoTheia
This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kidney Stone Retrieval
All patients in this group will have the EndoTheia FlexStone basket used to assist in the retrieval of kidney stones
Device: Kidney Stone Retrieval
Using FlexStone Basket aimability to retrieve kidney stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 Post-Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EndoTheia

Collaborators

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Estimated)

September 8, 2024

Study Completion (Estimated)

September 8, 2024

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB231189

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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