VSF1.01 for Hearing loss

Inclusion criteria

• {"criterion_text":"-Men, women*, inter/diverse aged ≥ 18 years *Women without childbearing potential defined as follows: •\tat least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or •\thysterectomy or uterine agenesis or •\t≥ 50 years and in postmenopausal state > 1 year or *Women of childbearing potential: •\twho are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or •\twho have sexual relationships with female partners only and/or with sterile male partners or •\twho are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception** from the time of screening until end of the clinical trial. **The following methods of contraception are acceptable (failure rate of < 1% per year/highly effective): -\tcombined (estrogen and progesterone containing) hormonal contraception (oral/intravaginal/transdermal) associated with inhibition of ovulation, -\tprogestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, -\tintrauterine device (IUD), -\tintrauterine hormone-releasing system (IUS)\n-Signed written informed consent from subject capable of understanding all information and to give full informed consent\n-Functional deaf patients (profound hearing loss with or without non-functional residual hearing in the low frequencies i.e. 125 Hz: 45 dB - 95 dB; 250 Hz: 50 dB - 105 dB; 500 Hz: 55 dB - 110 dB; 750 Hz and higher: 65 dB or below) that are candidates for cochlear implantation."}

Exclusion criteria

• {"criterion_text":"-Patients with prior ear surgery\n-Hypersensitivity to any of the components of the medications used (such as Ringer’s Lactate (excipient); any residuals from cell culture or raw materials used for pharmaceutical upstream and downstream processing to generate VSF1.01).\n-Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)\n-Intolerance to medical grade silicone\n-Patients with acute or chronic otitis media\n-Patients with keloid disorder\n-Patients with inner ear malformations\n-Comorbidities concerning the central nervous system\n-Malignancies of any type\n-Kidney disease with elevated blood values: creatinine >1.5x above upper limit of normal (ULN), eGFR or creatinine clearance 59 mL/min/1.73 m2 (according to grade ≥2 CTCAE v5.0).\n-Liver disease with elevated blood values: bilirubin >1.5x ULN, AST/ALT >3.0x ULN, ALP and y-GT >2.5x ULN, LDH >ULN, international normalized ratio (INR) >1.5x baseline if on anticoagulation, albumin <3 g/dL (according to grade ≥2 CTCAE v5.0).\n-Suspected or verified pregnancy or breastfeeding"}

Primary endpoints

• {"endpoint_text":"-In order to assess safety of patients, a clinical evaluation of each patient is performed. Number and severity of adverse events (AEs/SAEs) will be recorded and documented and represent the primary endpoints of the ESCRT study to create a safety profile","definition_or_measurement_approach":"Clinical evaluation of each patient; recording and documentation of number and severity of adverse events (AEs/SAEs) to create a safety profile."}

Secondary endpoints

• {"endpoint_text":"-Ad 1) the measurement of electrically evoked compound action potential (eCAP; eCAP growth function) in order to evaluate health of the auditory nerve","definition_or_measurement_approach":"Measurement of electrically evoked compound action potential (eCAP; eCAP growth function) to evaluate auditory nerve health."}
• {"endpoint_text":"-Ad 2) Speech perception in quiet and in noise will be evaluated by use of the Freiburg monosyllable test (FBM), the Hochmair-Schulz-Moser sentence test (HSM; at a signal to noise ratio (SNR) of 10 dB and a SNR of 5 dB) and the Oldenburger sentence test (OLSA, measuring the SNR that allows 50% speech intelligibility).","definition_or_measurement_approach":"Speech perception assessed using Freiburg monosyllable test (FBM), HSM sentence test at SNR 10 dB and 5 dB, and OLSA measuring SNR for 50% intelligibility."}
• {"endpoint_text":"-Ad 3) Air and bone conduction from 125 Hz – 16,000 Hz will be measured by pure tone audiometry to assess the hearing thresholds.","definition_or_measurement_approach":"Pure tone audiometry measuring air and bone conduction across 125 Hz–16,000 Hz to assess hearing thresholds."}
• {"endpoint_text":"-Ad 4) Impedance levels of the electrode contacts are determined and are a measure to rule out pathological levels of impedances (which can be an indication for ossification, intensive fibrosis formation, or failure of electrodes). This is part of the clinical routine investigation after cochlear implantation.","definition_or_measurement_approach":"Determination of electrode contact impedance levels as a routine clinical measure to detect pathological impedances indicating ossification, fibrosis, or electrode failure."}

Germany

Earliest CTIS Part Ii Submission Date

02-08-2024

Latest Decision Or Authorization Date

10-10-2024

Processing Time Days

69

Number Of Sites

1

Number Of Participants

11

Primary sponsor

Full Name

Medizinische Hochschule Hannover

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Austria","full_name":"Paracelsus Medizinische Privatuniversitaet Salzburg","duties_or_roles":"10","organisation_type":"Educational Institution"}
• {"country":"Austria","full_name":"Paracelsus Medizinische Privatuniversitaet Salzburg","duties_or_roles":"IMP supply","organisation_type":"Educational Institution"}