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Trial Title:
Evaluation of 3D Ultrasound in Brain Tumor Surgery
NCT ID:
NCT05956977
Condition:
Residual Tumor
Conditions: Official terms:
Neoplasm, Residual
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
retrospective matched pair control
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Device
Intervention name:
resection with help of 3D ultrasound
Description:
see above
Arm group label:
prospective arm
Summary:
Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of
resection. Benefit for surgery, neurological outcome, accuracy and image quality are
secondary outcome parameters. Control group is a retrospective matched pair cohort.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross
total resection of lesion
Exclusion Criteria:
- no ability for informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Tübingen
Address:
City:
Tübingen
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Constantin Roder, Prof. Dr. me.d
Facility:
Name:
University of Ulm
Address:
City:
Ulm
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jan Coburger, MD
Email:
jan.coburger@uni-ulm.de
Start date:
October 1, 2021
Completion date:
March 31, 2025
Lead sponsor:
Agency:
University of Ulm
Agency class:
Other
Collaborator:
Agency:
Brainlab AG
Agency class:
Industry
Source:
University of Ulm
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05956977
