Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery

May 6, 2022 updated by: Dr. Arkadi Yakirevitch, Sheba Medical Center

Identification and preservation of internal carotid artery during endoscopic nasopharyngectomy in cases of malignancy is a main difficulty of this kind of surgery, especially when anatomy is distorted by previous radiation. Intraoperative navigation based on preoperative imaging cannot remain precise throughout the process of resection. We aim to check a feasibility of internal carotid artery localization with the help of transnasal ultrasonic scanning. The most appropriate for this method existing device is an echocardiography system with pediatric transesophageal transducer.

We plan to use it in 20 patients undergoing elective surgery for inflammatory sino-nasal disease. After initiatioin of general anesthesia and local decongestion, transducer will be placed transnasally to nasopharynx in order to scan a parapharyngeal space.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

  • Israel
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center

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:

Indication for endoscopic nose and paranasal sinuses surgery

Exclusion Criteria:

Previous nasopharyngeal surgery

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Consecutive eligible patients requiring endoscopic surgery for sinonasal pathology Transnasal localization of internal carotid artery with TEE ECHO device will be performed
Device: EPIQ 5
As described in summary Trade name of the device Philips EPIQ 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
distance from nasopharynx surface to a closest wall of internal carotid arter
Time Frame: 3 minutes
cm
3 minutes

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

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 (Actual)

August 5, 2019

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 5450-18-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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