Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
A legfontosabb adatok
- Hol
- Deerfield Beach (Egyesült Államok)A helyszín megnézése
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 22 és 120 év között vagy?
Forrás: NCT06542289: ki vehet részt
Helyszínek itt: Egyesült Államok
- Rand Eye InstituteDeerfield Beach, Egyesült ÁllamokContact: Alison Rand, MDNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Neurotrigger Ltd
- Azonosító
- NCT06542289
- A regiszteradat frissítve
- 2025. június 10.
- Eredeti leírás
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.A teljes eredeti leírásKevesebb
Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
Bevonási feltételek: 22 years of age or older; Unilateral facial palsy due to any of the following: Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma; A deficit in eye closure during blinking, defined as a mean blink score ≤2.0 in the study eye on the scale by Mäkelä, et al, as graded by the investigator; Willing and able to comply with the study procedures and follow-up; Willing and able to provide informed consent; English, Spanish, or Hebrew, Arabic -speaking; In a trial with the BlinkER System, the device produces blinks sufficient to cover the pupil in the study eye, defined as a mean grade ≥ 3.0 on the Mäkelä scale, as graded by the investigator; Participant successfully completes BlinkER System training and certification.
Kizáró feltételek: History of prior intervention that is providing closure of the eyelids (e.g., facial reanimation, complete tarsorrhaphy surgery, etc.); Participation in another ophthalmic clinical trial within one year prior to enrollment. Participant must also be willing to refrain from another ophthalmic study for the duration of the study; Bilateral facial paralysis (for example Parkinson's Disease); History of diabetic neuropathy, unstable cardiovascular disease, neurologic disease causing severe cognitive or motor impairment, severe immunological deficiency, or malignant diseases that are not in remission; Signs of corneal infection, severe ocular surface inflammation, or significant periorbital skin inflammation/infection; Suspected or diagnosed epilepsy; Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device; Known allergy to any of the patient-contacting materials of the BlinkeER electrode (i.e. polyethylene (PET) film tape or hydrogel); Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the participant to the protocol; Has an implanted eyelid weight in the study eyelid; Cancerous lesions in the area where the BlinkER system electrodes will be applied; Cornea or iris abnormalities that preclude visualization of the pupil; Cranial nerve V palsy or neurotrophic keratitis; Synkinesis that results in eyelid closure; Participants who are pregnant or nursing.