ICG Use in Angiography for Nasoseptal Flap Harvest (ICG)

April 13, 2017 updated by: Daniel Prevedello, Ohio State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG
Angiography with administered ICG
Drug: indocyanine green
ICG 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.
Time Frame: During surgery
The researcher will administer 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. This study will determine feasibility of other larger clinical trials using this method.
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Daniel Prevedello, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 17, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013H0414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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