FlexStone Enabled Kidney Stone Retrieval

NCT06320860 | Completed FDA Device

• 1 other identifier: IRB231189
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Kidney Stone Retrieval

EXPERIMENTAL

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

Device: Kidney Stone Retrieval

Interventions

Kidney Stone Retrieval DEVICE

Using FlexStone Basket aimability to retrieve kidney stones

Kidney Stone Retrieval

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 are unable or unwilling to provide informed consent

Sponsors & Collaborators

• EndoTheia: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 20, 2024
• Study Start: March 8, 2024
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

US (1)