Clinical Trials Directory

Trials / Completed

CompletedNCT02117310

ICG Use in Angiography for Nasoseptal Flap Harvest

Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Sphenopalatine Artery Location and Patency in Harvesting and Positioning a Pedicled Nasoseptal Mucosal Flap in Endoscopic Endonasal Cranial Base Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Ohio State University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This study is being done to determine if it is feasible to use angiography during endo-nasal surgery. During the angiography indocyanine green (ICG) will be injected into the patients IV tubing to help see the arteries. ICG is routinely used in vascular surgeries on the brain but not for endo-nasal surgery. The purpose of this study is to see how well intraoperative angiography using ICG can be done during endonasal surgery.

Conditions

Interventions

TypeNameDescription
DRUGindocyanine greenICG will be administered 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.

Timeline

Start date
2015-03-01
Primary completion
2015-11-01
Completion
2015-11-01
First posted
2014-04-17
Last updated
2017-04-17
Results posted
2017-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02117310. Inclusion in this directory is not an endorsement.