Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542289
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-Arm Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Paralysis
Brief Summary:
Prospective single-arm multicenter single-masked pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy
Detailed Description:
A single-arm multicenter study will be conducted to evaluate the safety and effectiveness of the Blinker system in achieving eyelid closure over a 3-month period in individuals with facial nerve palsy The study aims to enroll at least 80 participants for evaluation Participants will use the investigative device for a duration of 3 months
All subjects will undergo the following visits ScreeningBaseline Day 0 Day 1 Week 1 Week 2 Month 1 Month 2 Remote visit and Month 3
The inclusion criteria for participants will be unilateral facial palsy due to conditions such as Bells palsy Ramsay Hunt syndrome malignant or benign tumor resection Lyme disease cerebrovascular accident hemorrhagic or ischemic or trauma
The estimated total study duration is 12 months
All subjects will undergo the following visits ScreeningBaseline Day 0 Day 1 Week 1 Week 2 Month 1 Month 2 Remote visit and Month 3
The inclusion criteria for participants will be unilateral facial palsy due to conditions such as Bells palsy Ramsay Hunt syndrome malignant or benign tumor resection Lyme disease cerebrovascular accident hemorrhagic or ischemic or trauma
The estimated total study duration is 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None