NCT05891002

Brief Summary

This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial. The goal is to determine whether the robotic procedure to be examined can achieve a clinically acceptable value of at least 90% in terms of diagnostic yield.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Nov 2023Jun 2026

First Submitted

Initial submission to the registry

May 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

May 26, 2023

Last Update Submit

December 10, 2024

Conditions

Intracranial Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    Determine the percentage of diagnostically significant biopsies determined histologically

    24 months

Secondary Outcomes (2)

  • Target point and entry point error

    24 months

  • Time for procedure

    24 months

Study Arms (1)

Biopsy Patient

Patient with a confirmed intracranial neoplasm scheduled for a biopsy with Cirq® Robotic Alignment Module Cranial and registration via Auto-Registration Software Universal Automatic Image Registration Cranial and Loop-X® Mobile Imaging Robot.

Device: Cirq® Robotic Alignment Module Cranial

Interventions

Cirq® Robotic Alignment Module CranialDEVICE

Robotic navigation for cranial biopsy procedure

Biopsy Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 consecutive patients who are planned to undergo a brain biopsy will be included. Since this is a confirmatory study, a sample size calculation was not able to be performed.

You may qualify if:

  • Intracranial lesion and the indication for a diagnostic stereotactic biopsy validated by the neurosurgical staff
  • Ability to consent to the procedure

You may not qualify if:

  • Pregnancy
  • Contraindications on narcosis, operation, CT scan, MRI scan and/or Gadolinium contrast agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre Hospitalier Universitaire (CHU) d'Angers health establishment

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jean-Michel Lemée, MD

    University Hospital, Angers

    STUDY DIRECTOR

Central Study Contacts

Christine M Bayer, PhD

CONTACT

+49 89 99 15 68christine.bayer@brainlab.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 6, 2023

Study Start

November 1, 2023

Primary Completion

October 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations

FR(1)