ICG Use in Angiography for Nasoseptal Flap Harvest (ICG)
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ClinicalTrials.gov Identifier: NCT02117310 |
Recruitment Status :
Completed
First Posted : April 17, 2014
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Skull Base Neoplasms | Drug: indocyanine green | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Study Start Date : | March 2015 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | November 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: ICG
Angiography with administered ICG
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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. |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117310
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Daniel Prevedello, MD | Ohio State University |
Responsible Party: | Daniel Prevedello, Associate Professor, Ohio State University |
ClinicalTrials.gov Identifier: | NCT02117310 |
Other Study ID Numbers: |
2013H0414 |
First Posted: | April 17, 2014 Key Record Dates |
Results First Posted: | April 17, 2017 |
Last Update Posted: | April 17, 2017 |
Last Verified: | March 2017 |
Skull Base Neoplasms Skull Neoplasms Bone Neoplasms Neoplasms by Site |
Neoplasms Bone Diseases Musculoskeletal Diseases |