AzTrials
AzTrials

Aneurysm Cerebral3 DNCT05324605

Personalized Treatment Planning in Intracranial Aneurysm Surgeries.

An observational study of Aneurysm Cerebral, run by Prof. Dr. med. Serge Marbacher at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients who will undergo a intracranial aneurysm (IA) surgery are educated concerning their disease and the surgical procedure.The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aneurysm Cerebral
What is being tested?
Questionnaire and use of 3 D tools
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2021to 31 Dec 2023
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: The study population are patient with a age >18 years, diagnosed with a intracranial aneurysma , requiring surgery. The eligibility is evaluated and prior surgery, preoperative assessment by CTA and 3D-DSA have been performed. After screening a non routine consultation with the 3 D method visualization is scheduled. Finally, patients will be scheduled for surgery according to our standard procedure.

Who may be able to join

  • All patients undergoing elective surgery for non-ruptured IA during the study period will be considered for inclusion. Patients are included if they are at least 18 years old and are able to give informed consent and signed the informed consent form.

Who cannot join

  • Patients with ruptured or mycotic IA are not considered. Furthermore, patients elected for IA surgery that are younger than 18 years old, as well as patients who are unable to give informed consent (e.g. neurological impairments) will not be included.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Kantonsspital Aarau AG

    Aarau, Canton of Aargau, 5001

Other trials in Switzerland

About this study

Official title: Personalized 3D Virtual and Printed Model Versus Conventional Images for the Education of the Treatment Planning in Intracranial Aneurysm Surgeries.

Patients who will undergo a intracranial aneurysm (IA) surgery are educated concerning their disease and the surgical procedure.The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Read the detailed description

Patient understanding of their medical condition and treatment satisfaction has gained increasing attention in medicine. As for neurosurgical conditions however, the treatment plan is often difficult for patients to comprehend, with many of them having an inaccurate understanding of the involved anatomy.

Novel technologies therefore may play a role in facilitating patient education. In particular, conventional 2D images makes it sometimes difficult for surgeons to inform their patients about the planned intervention and potential complications. This is why new modalities have been developed for patient information and may have further an impact on resident education to better estimate the treatment plan and potential complication. For the latter, given that intracranial aneurysms (lAs) are increasingly treated via endovascular methods, training opportunities are reduced and understanding of the vascular anatomy can become difficult.

The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Being tested
Questionnaire and use of 3 D tools
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire and use of 3 D toolsProcedure or surgery

    Resulting computer tomography(CT) results are transferred to a 3 D projection. Patients will be asked to wear 3 D glasses to be able visualizing the diagnosed vascular pathology. The physician will explain the disaese and treatment. The patient is ask to fill out a questionnaire post 3D consulting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. accuracy of the planned intervention and clip placement.

    Assessment of the 3D models regarding the accuracy of the planned intervention. In specific the following surgical steps are evaluated and assessed during aneurysm clipping and compared to the ideal preoperative forecast based on the 3D model (GRF_clip anticipation): Temporary clips: (1) number of temporary clips; (2) left- or right-handed application; (3) position on parent artery; (4) length of the clip; (5) shape of the clip. Permanent clips: (6) number of permanent clips; (7) left- or right-handed application; (8) length of the clip; (9) shape of the clip.

    Measured: 6 months post interventional

Secondary outcomes (1)

  1. patient education

    Assessment of ischemia (large and perforating artery compromise), time of temporary clip occlusion, morbidity, clinical outcome., To investigate the impact of personalized 3D printed model on patient information before surgery, study participants will be presented with their individual 3D printed model and a questionaire to analze an improvement in their understanding of basic anatomy, the planned surgical procedure, and understanding the complications related to the surgery will be assessed (GRF_patient satisfaction).

    To further determine if 3D printed models can be used to improve intraoperative pattern recognition and be a valuable adjunct in neurosurgical resident education, a comparison of conventional imaging with CT-scan, 3D-RA, 3D model will be assessed (GRF_resident education).

    Measured: 6 months post interventional

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05324605
Sponsor's protocol ID
3 D
Acronym
3 D
Status last verified
Oct 2024
First submitted
6 Apr 2022
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis. Lancet Neurol. 2011 Jul;10(7):626-36. doi: 10.1016/S1474-4422(11)70109-0.

    PubMed 21641282

  • Andereggen L, Gralla J, Andres RH, Weber S, Schroth G, Beck J, Widmer HR, Reinert M, Raabe A, Peterhans M. Stereolithographic models in the interdisciplinary planning of treatment for complex intracranial aneurysms. Acta Neurochir (Wien). 2016 Sep;158(9):1711-20. doi: 10.1007/s00701-016-2892-3. Epub 2016 Jul 14.

    PubMed 27416860

  • Kimura T, Morita A, Nishimura K, Aiyama H, Itoh H, Fukaya S, Sora S, Ochiai C. Simulation of and training for cerebral aneurysm clipping with 3-dimensional models. Neurosurgery. 2009 Oct;65(4):719-25; discussion 725-6. doi: 10.1227/01.NEU.0000354350.88899.07.

    PubMed 19834377

  • Russin J, Babiker H, Ryan J, Rangel-Castilla L, Frakes D, Nakaji P. Computational Fluid Dynamics to Evaluate the Management of a Giant Internal Carotid Artery Aneurysm. World Neurosurg. 2015 Jun;83(6):1057-65. doi: 10.1016/j.wneu.2014.12.038. Epub 2014 Dec 22.

    PubMed 25541083

  • Slichter SJ. Platelet transfusion therapy. Hematol Oncol Clin North Am. 1990 Feb;4(1):291-311.

    PubMed 2179213

  • Tanabe J, Ishikawa T, Moroi J, Sakata Y, Hadeishi H. Impact of Right-Sided Aneurysm, Rupture Status, and Size of Aneurysm on Perforator Infarction Following Microsurgical Clipping of Posterior Communicating Artery Aneurysms with a Distal Transsylvian Approach. World Neurosurg. 2018 Mar;111:e905-e911. doi: 10.1016/j.wneu.2018.01.002. Epub 2018 Jan 8.

    PubMed 29325945

  • Roszelle BN, Babiker MH, Hafner W, Gonzalez LF, Albuquerque FC, Frakes DH. In vitro and in silico study of intracranial stent treatments for cerebral aneurysms: effects on perforating vessel flows. J Neurointerv Surg. 2013 Jul;5(4):354-60. doi: 10.1136/neurintsurg-2012-010322. Epub 2012 Jun 26.

    PubMed 22735859

  • Gruter BE, d'Allens L, Trost P, Wanderer S, Schubert GA, Gruber P, Berberat J, Steiger HJ, Cattaneo M, Andereggen L, Remonda L, Marbacher S. Risk Assessment of Intracranial Aneurysm Remnants After Microsurgical Clipping Based on 3D-Digital Subtraction Angiography. Oper Neurosurg. 2026 Apr 15. doi: 10.1227/ons.0000000000002035. Online ahead of print.

    PubMed 41983681

Questions about this trial

What is this clinical trial studying?

An observational study of Aneurysm Cerebral, run by Prof. Dr. med. Serge Marbacher at 1 site in Switzerland.

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 1 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: finished, as of the sponsor's last update on 17 Oct 2024. 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 Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

accuracy of the planned intervention and clip placement. (time frame: 6 months post interventional). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05324605, which also lists 8 linked publications.

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 17 Oct 2024.

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