Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05515705
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-08-23
Brief Title:
First-in-human Navigation Endoscopic Ultrasound EUS System Clinical Study
Sponsor:
IHU Strasbourg
Organization:
IHU Strasbourg
Study Overview
Official Title:
First-in-human Navigation Endoscopic Ultrasound EUS System Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APEUS-Nav1
Brief Summary:
The implementation of Echo-endoscopy or EUS for Endoscopic UltraSound is limited by the difficulty of obtaining quality EUS procedures since the accuracy of the method relies on the endoscopists abilities Indeed both cognitive and technical skills are required for endoscopic manipulation and image interpretation as well as a thorough knowledge of intra-abdominal anatomy The EUS-GPS system aims to assist the operator in understanding the orientation and location of the probe tip within the patient For that a Global Positioning System GPS for EUS procedures is intraoperatively provided using a 3D-based model based on recorded preoperative data
In this clinical investigation the EUS GPS system is intended to help EUS operators to correctly navigate towards the pancreatic gland perform a comprehensive assessment of the area of interest and aid in the detection and identification of lesions
In this clinical investigation the EUS GPS system is intended to help EUS operators to correctly navigate towards the pancreatic gland perform a comprehensive assessment of the area of interest and aid in the detection and identification of lesions
Detailed Description:
Since its emergence in the 1980s endoscopic ultrasound EUS is considered as one of the most accurate tools for the evaluation of the pancreatic gland and other gastrointestinal GI disorders Despite its utility the practice of EUS is still far from being part of every endoscopy suite due to its high set-up cost and the relative scarcity of credentialed experts EUS implementation worldwide has been limited by the difficulty of achieving quality EUS procedures since the accuracy of the method relies on the endoscopists abilities Both cognitive and technical competencies are required for endoscopic manipulation and image interpretation as well as extensive knowledge of intraabdominal anatomy
The aim of the APEUS Augmented Pancreatic Endoscopic UltraSound project is to overcome these two main difficulties by providing a Global Positioning System GPS-like intraoperative navigation for EUS procedures using a 3D-based model on registered preoperative data The hypothesis is that thanks to this tool the procedures time would be shortened and the pancreas and its lesions would be completely imaged This would reduce the demand for experts guiding trainees and shorten the EUS learning curve
This first-in-human clinical study will enable the assessment of safety and qualitative performance of the EUS-GPS solution The primary objective is to evaluate the EUS navigation systems procedure duration compared to standard procedure times patient group with the EUS-GPS system vs control group without
The aim of the APEUS Augmented Pancreatic Endoscopic UltraSound project is to overcome these two main difficulties by providing a Global Positioning System GPS-like intraoperative navigation for EUS procedures using a 3D-based model on registered preoperative data The hypothesis is that thanks to this tool the procedures time would be shortened and the pancreas and its lesions would be completely imaged This would reduce the demand for experts guiding trainees and shorten the EUS learning curve
This first-in-human clinical study will enable the assessment of safety and qualitative performance of the EUS-GPS solution The primary objective is to evaluate the EUS navigation systems procedure duration compared to standard procedure times patient group with the EUS-GPS system vs control group without
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None