To Assess Feasibility of the New Application Clinical Trial
Official title:
Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery
NCT number | NCT03838640 |
Other study ID # | 5450-18-SMC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 5, 2019 |
Est. completion date | May 1, 2022 |
Verified date | May 2022 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | May 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Indication for endoscopic nose and paranasal sinuses surgery Exclusion Criteria: Previous nasopharyngeal surgery |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Tel Hashomer |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | distance from nasopharynx surface to a closest wall of internal carotid arter | cm | 3 minutes |