First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study

NCT05515705 | Terminated

• 1 other identifier: 22-003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 endoscopist's 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.

Conditions

Pancreatic Disease

Keywords

Endoscopic ultrasound; EUS; Biliopancreatic; Pancreatic cancer; PDAC; EUS navigation; Education; Training; Learning curve; Quality indicators

Outcome Measures

Primary Outcomes (1)

• Evaluation of the EUS navigation system's procedure duration compared to standard procedure times

  Collect of peroperative duration for registration, insertion, navigation to cardia, navigation from the cardia to the pancreas, pancreas examination, therapeutic step and overall duration of the procedure (quantitative). Results will be compared between cases with (Groups EUS-NS) and without (Group EUS alone) use of the navigation system

  1 day

Secondary Outcomes (8)

• Assessment of the EUS navigation system in terms of reliability and safety

  1 day

• Comparison of the EUS navigation system's procedure duration depending on the order the EUS-GPS is used

  1 day

• Assessment of the system's ease-of-use (integration in the standard-of-care workflow) compared to the standard procedure by the mean of a questionnaire

  1 day

• Assessment of the system's stressfulness compared to the standard procedure by the mean of a questionnaire

  1 day

• Collect adverse events, adverse device effects and device deficiencies

  1 month

Study Arms (3)

EUS-NS +

EXPERIMENTAL

EUS with the navigation system first on, then off

Device: EUS navigation system

EUS-NS -

EXPERIMENTAL

EUS with the navigation system first off, then on

Device: EUS navigation system

EUS group

NO INTERVENTION

EUS alone

Interventions

EUS navigation system DEVICE

Incorporation of the EUS navigation system to the EUS scope

EUS-NS +; EUS-NS -

Eligibility Criteria

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

You may qualify if:

• Man or woman over the age of 18 years old
• Patient having a EUS procedure for pancreas study planned within the frame of his or her clinical care.
• Patient whom pre-operative imaging indicates one lesion with a good definition on the triphasic CT scan done within the 60 days prior to the EUS.
• Patient able to receive and understand information related to the study and give his or her written consent
• Patient affiliated to the French social security system

You may not qualify if:

• Patient unable to give informed consent
• Patient with altered anatomy of the upper digestive tract due to previous surgery
• Patient with known abnormal anatomy of the upper digestive tract
• Patient wearing a metal implantable device (pacemaker, etc.)
• Patient presenting, according to the investigator's judgment, a disease which may prevent participation in the procedures provided for by the study
• Patient with an ASA (American Society of Anesthesiologists) score \>2
• Patient with multiple pancreatic lesions.
• Patient unable to tolerate general anaesthesia
• Patient with a body mass index (BMI) \< 23 and \> 40
• Patient with weight variations of \>10% between the date on which the CT scan was performed and the date of the procedure.
• Pregnant or lactating patient
• Patient under guardianship or trusteeship
• Patient under the protection of justice of deprives of liberty
• Patient in situation of emergency

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Pôle Hépato-Digestif, NHC

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Pancreatic Diseases; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Leonardo SOSA VALENCIA, MD

  IHU Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: January 10, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 1, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)