Aortic AneurysmCOM-ENDONCT04714268
Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
An observational study of Aortic Aneurysm and Iliac Aneurysm, run by Therenva at 1 site in France.
Trial summary
The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Iliac Aneurysm, Stenoses, Aortic
- What is being tested?
- Aorto-iliac endovascular procedure
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients with unilateral or bilateral common iliac aneurysm or stenosis, treated with endovascular technique
Who may be able to join
- Unilateral or bilateral aorto-iliac or iliac aneurysm/stenosis
- Suitable for endovascular repair
- Major patients
- Patients not opposed to their participation in the study
Who cannot join
- Patients requiring conventional surgical revascularization.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Rennes
Rennes, 35000
Adrien Kaladji, MD, PhD
About this study
The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.
Read the detailed description
Minimally invasive endovascular interventions are increasingly replacing conventional surgeries, and have become the therapeutic benchmark for a large number of pathologies thanks in particular to advances in image-guided therapy. Therenva offers a comprehensive and consistent lightweight navigation solution (EndoNaut®) for endovascular procedures. This navigation station makes it possible to secure and guide the interventional gesture by providing relevant information extracted during the preoperative phase. This information is rendered in augmented reality using artificial intelligence algorithms and digital simulation. This alternative solution to a hybrid room, but which offers equivalent functionality, is compatible with all operating rooms, regardless of the interventional environment. Benefits of imaging fusion remain to be assessed on a larger scale. The aim of this multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.
- Being tested
- Aorto-iliac endovascular procedure
- Medical subject headings
- Aortic Aneurysm, Iliac Aneurysm, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aorto-iliac endovascular procedureProcedure or surgery
Percutaneous procedure with stent placement
| Study group | Role | What they receive |
|---|---|---|
| Procedures with EndoNaut | Endovascular interventions using the EndoNaut workstation. 3D image fusion is used for overlaying arterial information on top of fluoroscopic images Receives: Procedure: Aorto-iliac endovascular procedure | |
| Procedures without EndoNaut | Control group, endovascular interventions without 3D image fusion Receives: Procedure: Aorto-iliac endovascular procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of contrast product used during the routine care procedure (ml)
Volume are reported in mL
Measured: At enrollment
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
Parameter given by the X-ray imaging device
Measured: At enrollment
Irradiation parameters: dose-area quantification (mGy/m2)
Parameter given by the X-ray imaging device
Measured: At enrollment
Irradiation parameters: measurement of air Kerma (mGy)
Parameter given by the X-ray imaging device
Measured: At enrollment
Secondary outcomes (1)
Procedure time (min)
Total procedure time
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therenva
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rennes University Hospital, Douai hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Brest, Polyclinique Bordeaux Nord Aquitaine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714268
- Sponsor's protocol ID
- 002
- Acronym
- COM-ENDO
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
- ClinicalTrials.gov ID
- NCT04714268
- Acronym / sponsor ID
- COM-ENDO / 002
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- TherenvaIndustry (pharma, biotech, devices)
- Collaborators
- Rennes University Hospital, Douai hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Brest, Polyclinique Bordeaux Nord Aquitaine
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.
Detailed description
Minimally invasive endovascular interventions are increasingly replacing conventional surgeries, and have become the therapeutic benchmark for a large number of pathologies thanks in particular to advances in image-guided therapy. Therenva offers a comprehensive and consistent lightweight navigation solution (EndoNaut®) for endovascular procedures. This navigation station makes it possible to secure and guide the interventional gesture by providing relevant information extracted during the preoperative phase. This information is rendered in augmented reality using artificial intelligence algorithms and digital simulation. This alternative solution to a hybrid room, but which offers equivalent functionality, is compatible with all operating rooms, regardless of the interventional environment. Benefits of imaging fusion remain to be assessed on a larger scale. The aim of this multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedures with EndoNaut | – | Procedure: Aorto-iliac endovascular procedureEndovascular interventions using the EndoNaut workstation. 3D image fusion is used for overlaying arterial information on top of fluoroscopic images |
| Procedures without EndoNaut | – | Procedure: Aorto-iliac endovascular procedureControl group, endovascular interventions without 3D image fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with unilateral or bilateral common iliac aneurysm or stenosis, treated with endovascular technique
Key inclusion criteria (4 listed)
- Unilateral or bilateral aorto-iliac or iliac aneurysm/stenosis
- Suitable for endovascular repair
- Major patients
- Patients not opposed to their participation in the study
Key exclusion criteria (1 listed)
- Patients requiring conventional surgical revascularization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aorto-iliac endovascular procedurePercutaneous procedure with stent placement | Procedure or surgery | Procedures with EndoNaut, Procedures without EndoNaut |
Primary outcome
Volume of contrast product used during the routine care procedure (ml)
Time frame: At enrollment
Volume are reported in mL
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
Time frame: At enrollment
Parameter given by the X-ray imaging device
Irradiation parameters: dose-area quantification (mGy/m2)
Time frame: At enrollment
Parameter given by the X-ray imaging device
Irradiation parameters: measurement of air Kerma (mGy)
Time frame: At enrollment
Parameter given by the X-ray imaging device
1 secondary outcome
Procedure time (min)
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Iliac Aneurysm, run by Therenva at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florent Lalys, PhD (+33789833846, florent.lalys@therenva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of contrast product used during the routine care procedure (ml) (time frame: At enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.