Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576661
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology Examination of Surgeon Behavior and Post-operative Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology Examination of Surgeon Behavior and Post-operative Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELITE
Brief Summary:
The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons behavior during ureteroscopy while using the ureteroscope LithoVue Elite
Detailed Description:
Despite advances in surgical techniques and technology preventable adverse events still occur in the operating room with half of them attributed to poor non-technical skills of surgical teams Therefore it is essential to observe and measure surgeons intraoperative non-technical skills and provide structured feedback to improve patient safety The new LithoVue Elite disposable ureteroscope has the potential to impact surgeons behavior during ureteroscopy as it enables the measurement of real-time intrarenal pressures The study is designed to evaluate urologists behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None