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

ConditionPancreatic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIHU Strasbourg

About this trial

The complexity of the medical expertise required for endoscopic manipulation and image interpretation complicates the implementation of echo-endoscopy (or EUS for "Endoscopic Ultrasound").

The "EZ-EUS" system is designed to help the operator understand the orientation and the position of the probe tip in the patient. This system offers navigation similar to that of the Global Positioning System (GPS), but for EUS procedures. To achieve this, it uses a 3D model based on scanner imaging data recorded before the procedure.

In this study, the intended purpose of the "EZ-EUS" system is to help echo-endoscopy operators to easily identify and assess the pancreatic gland, and to facilitate the detection of any lesions.

The hypothesis is that, thanks to this tool, procedure times will be shortened, and the pancreas and its lesions will be fully imaged to facilitate their localization and characterization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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, a suspicion of lesion, chronic pancreatitis or fatty pancreas.

Patient with a good definition on the CT scan done within the year to the EUS.

Disqualifiers

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 pacemaker.

Patients with comorbidities that may increase the risk of perforation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • endoscopic ultrasound with navigation system

    Device

    Use of the EZ-EUS navigation system during the procedure

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: EUS with EZ-EUS navigation systemExperimental treatment 1 intervention
Group B: Standard EUSNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Comparison of the examination period duration between the two groups (experimental vs control)

Time frame
1 day

Secondary outcomes

1

Assessment of the EUS navigation system for patient safety

Rate of adverse events, adverse device effects and complications

Time frame
1 month
2

Assessment of the system's ease-of-use and technological maturity

Qualitative assessment of the system's ease-of-use and technological maturity using questionnaires. Appropriate statistical test will be used to compare each procedure. Results will be presented numerically and graphically.

Time frame
1 day
3

Assessment of the EUS navigation system for reliability

Rate of device deficiencies during the procedure

Time frame
1 day
4

Evaluation of the time required to perform individual step duration

Comparison of the duration of each individual step

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IHU Strasbourg

Lead sponsor

IRCAD

Collaborator

Source ClinicalTrials.gov
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