Evaluation of 3D Ultrasound in Brain Tumor Surgery

NCT ID: NCT05956977

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Residual Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

retrospective matched pair control
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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prospective arm

Use of 3D ultrasound intraoperative before intraoperative MRI

Group Type EXPERIMENTAL

resection with help of 3D ultrasound

Intervention Type DEVICE

see above

retrospective matched pair arm

no use of intraoperative ultrasound before intraoperative MRI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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resection with help of 3D ultrasound

see above

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brainlab AG

INDUSTRY

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Jan Coburger

apl. Prof. Dr. med. Jan Coburger, Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Tübingen

Tübingen, Baden Würtemberg, Germany

Site Status RECRUITING

University of Ulm

Ulm, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jan Coburger, apl. Prof. Dr. med.

Role: CONTACT

0822196 ext. 28858

Christian R Wirtz, Prof. Dr. med.

Role: CONTACT

0822196 ext. 0

Facility Contacts

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Constantin Roder, Prof. Dr. me.d

Role: primary

Jan Coburger, MD

Role: primary

References

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Aleo D, Elshaer Z, Pfnur A, Schuler PJ, Fontanella MM, Wirtz CR, Pala A, Coburger J. Evaluation of a Navigated 3D Ultrasound Integration for Brain Tumor Surgery: First Results of an Ongoing Prospective Study. Curr Oncol. 2022 Sep 15;29(9):6594-6609. doi: 10.3390/curroncol29090518.

Reference Type RESULT
PMID: 36135087 (View on PubMed)

Other Identifiers

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Neuro3DUS

Identifier Type: -

Identifier Source: org_study_id

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