Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05650710
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2022-12-06
Brief Title:
Intraoperative Ansa Cervicalis Nerve ACN Stimulation
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Intraoperative Identification and Stimulation of the Ansa Cervicalis Nerve Plexus
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACS
Brief Summary:
Recently published data suggest that stimulation of the infrahyoid strap muscles increases pharyngeal patency in patients with obstructive sleep apnea but the innervation of these muscles by the ansa cervicalis is variable The investigators propose a study examining the anatomic variation of the ansa cervicalis and the effect of neurostimulation on muscle recruitment
Detailed Description:
This is a single-arm physiology study Consenting patients undergoing neck dissection ND for cervical lymphadenectomy of level IV will undergo dissection of the ansa cervicalis nerves to the infrahyoid strap muscles Per routine care a large incision is made across the neck to provide surgeons access to the cervical lymph nodes for extirpation During this dissection the branches of the ansa cervicalis nerve plexus descending from the loop of the plexus and innervating the infrahyoid strap muscles the common trunk are dissected uni- or bilaterally For this study measurements and photosvideos of the common trunks will be taken An electrode will be placed on one or both common trunks to stimulate infrahyoid muscles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None