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ICG Use in Angiography for Nasoseptal Flap Harvest (ICG Trial)

N/A
Waitlist Available
Led By Daniel Prevedello, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during surgery
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This is a feasibility study in which indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal flap harvest will be necessary. The research entails administering ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

Eligible Conditions
  • Skull Base Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.

Side effects data

From 2016 Phase 3 trial • 99 Patients • NCT02279108
22%
lymphocele
10%
hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double Detection Indocyanine + Isotope
Isotope Detection Alone

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ICGExperimental Treatment1 Intervention
Angiography with administered ICG
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine green
FDA approved

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,734 Total Patients Enrolled
Daniel Prevedello, MDPrincipal InvestigatorOhio State University
2 Previous Clinical Trials
73 Total Patients Enrolled
~0 spots leftby Jan 2026
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