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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
Sponsor:
Information provided by (Responsible Party):
Daniel Prevedello, Ohio State University

Brief 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.

Condition or disease Intervention/treatment Phase
Skull Base Neoplasms Drug: indocyanine green Not Applicable

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.

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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Daniel Prevedello, MD Ohio State University
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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
Additional relevant MeSH terms:
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Skull Base Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases