Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05139277

Evaluation of the CONVIVO System

Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-02-06

30

Participants Needed

1

Research Sites

222 weeks

Total Duration

On this page

Sponsors

D

Dartmouth-Hitchcock Medical Center

Lead Sponsor

C

Carl Zeiss Meditec, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. The study team hypothesize that there will be a high degree of correlation between images obtained with the CONVIVO system and conventional histologic interpretation.

CONDITIONS

Official Title

Evaluation of the CONVIVO System

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (age >18)
  • Adults with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, or pituitary adenomas
  • Adults who are surgical candidates
  • Adults able to provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Children under 18 years old
  • Allergy to fluorescein sodium (FNa)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

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Research Team

L

Linton T Evans, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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