The subject has clinical evidence of facial paralysis requiring facial nerve repair from conditions or interventions that have or may result in paralysis.
Exclusion Criteria:
Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
Subjects requiring repair of the intracranial portion of the facial nerve. Subjects requiring repair involving an allograft or conduit except for procedures that require grafting of the other nerve branches when repairing the main facial nerve.
Subjects with Bell's palsy that have signs of spontaneous recovery by 12 months.
Subjects who, in the judgment of the investigator, are not likely to demonstrate meaningful recovery within 6 weeks due to significant facial muscle atrophy.
Subjects on chronic corticosteroid therapy within 14 days of repair.
The subject has documented history or clinical signs of:
Clinically significant neuropathy from any cause i.e., medications, chemotherapy, diabetes; Clinically significant systemic neuromuscular disease; Clinically significant local or systemic neurological deficit from other than the condition under study such as stroke; Or other treatments are known to affect the growth and/or physiology of the neural and vascular system with the exception of radiation therapy; The subject has a known allergy to polyethylene glycol (PEG) or human-grade silicone.
The subject is not able to strictly adhere to the rules of the current clinical protocol, e.g., significant mental health issues, homelessness, incarceration, intellectually or developmentally challenged without proper legal representation.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
NTX-001
Donnée non disponible
Solution #1, Solution #2 Active, Solution #3
Inconnu
Standard of Care
Donnée non disponible
Standard neurorrhaphy
Inconnu
NTX-001
État du recrutement
unknown
Solution #1, Solution #2 Active, Solution #3
Standard of Care
État du recrutement
unknown
Standard neurorrhaphy
Données à jour depuis :
17 août 2023
Description de l'étude
Description de l'étude
Résumé de l'étude
This study involves the use of an Investigational Product called NTX-001. It is a product used in the repair of nerve injuries. It is used in the operating room. The main purposes of this study are to 1) see how safe NTX-001 is when used in nerve repair and, 2) see if your nerve becomes functional in a shorter period of time when compared to what is normally done to treat nerve injuries.
Source : Importé depuis le centre
Facial paralysis can be a consequence of traumatic facial nerve injury, iatrogenic causes, malignancy, congenital syndromes, and viral infections. Prolonged paralysis can result in ocular complications, articulation difficulties, impaired feeding, and difficulty in conveying emotion through expressive movement. The current treatment for permanent facial paralysis is facial reanimation surgery, which encompasses a broad range of procedures that restore form and function to the paralyzed face.
The importance of understanding the health utility of facial paralysis and the value of facial reanimation surgery increases. PEG-fusion is a promising therapy for patients that have or will have nerve conditions or injuries resulting in facial palsy that can be addressed surgically. Patients that have clinical evidence of facial paralysis requiring facial nerve repair from conditions or interventions that have or may result in paralysis will be evaluated for participation. The primary objective is to assess the safety of NTX-001 across 12 months following the nerve repair. The study will measure improvement in Facial Grading System (FG) for efficacy. Additionally, measures will include an EMG evaluation for assessment of nerve function intraoperatively, image-based automatic facial landmark analysis, improvement in Facial Clinimetric Evaluation Scale score, and Patient Global Impression of Change Response (PGIC).
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
6
centres
DUKE UNIVERSITY MEDICAL CENTER
Durham
NORTH CAROLINA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
HOUSTON METHODIST
Houston
TEXAS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
MEMORIAL SLOAN KETTERING
New york
NEW YORK, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
RUSH UNIVERSITY MEDICAL CENTER
Chicago
ILLINOIS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
UNIVERSITY OF INDIANA
Indianapolis
INDIANA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
WASHINGTON UNIVERSITY
Saint louis
MISSOURI, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Source d'information
Dernière modification :
17 août 2023
Données à jour depuis :
22 mars
Origine des données :
clinicaltrials.gov
