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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG | Experimental | Angiography with administered ICG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indocyanine green | Drug | 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. |
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Prevedello, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ICG-Angiography With Administered ICG | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ICG-Angiography With Administered ICG | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This 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. | Posted | Count of Participants | Participants | During surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ICG-Angiography With Administered ICG | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Prevedello, Associate Professor | The Ohio State University | (614) 685-1965 | daniel.prevedello@osumc.edu |
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| ID | Term |
|---|---|
| D019292 | Skull Base Neoplasms |
| ID | Term |
|---|---|
| D012888 | Skull Neoplasms |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |