Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery

NCT ID: NCT03838640

Last Updated: 2022-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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To Assess Feasibility of the New Application

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Study group

Consecutive eligible patients requiring endoscopic surgery for sinonasal pathology Transnasal localization of internal carotid artery with TEE ECHO device will be performed

Group Type EXPERIMENTAL

EPIQ 5

Intervention Type DEVICE

As described in summary Trade name of the device Philips EPIQ 5

Interventions

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EPIQ 5

As described in summary Trade name of the device Philips EPIQ 5

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Indication for endoscopic nose and paranasal sinuses surgery

Exclusion Criteria

Previous nasopharyngeal surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Arkadi Yakirevitch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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5450-18-SMC

Identifier Type: -

Identifier Source: org_study_id

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