Personalized Treatment Planning in Intracranial Aneurysm Surgeries. (3 D)

April 6, 2022 updated by: Prof. Dr. med. Serge Marbacher

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of the planned intervention and clip placement.
Time Frame: 6 months post interventional
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.
6 months post interventional

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient education
Time Frame: 6 months post interventional

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).
6 months post interventional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. med. Serge Marbacher

Collaborators

Kantonsspital Aarau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3 D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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