N/A
N=5
ICG Use in Angiography for Nasoseptal Flap Harvest
Skull Base Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02117310 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery. — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- indocyanine green (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery. |
5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 and above
- Patients undergoing an EEA for cranial base pathology that may require nasoseptal flap harvest
Exclusion Criteria
- History of sulfa, iodide, or penicillin allergy
- Pregnant or breast feeding
- Preoperative lack of indication for nasoseptal flap harvest
- Previous anaphylactic reaction to ICG
Data sourced from ClinicalTrials.gov (NCT02117310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.