NL-OMON51025招募中不适用
A prospective, multi-center, single-arm, clinical investigation of the safety and performance of the Sentio system in users with mixed/conductive hearing losses and single sided deafness - BC101 - Safety and performance of the Sentio system
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Signed Informed Consent Form
- •2.Adult subjects (18 years or older)
- •3.Subjects with
- •3.1.conductive or mixed hearing losses with pure tone average (PTA) bone
- •conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated
- •ear better than or equal to 45 dB HL.
- •3.2.OR subjects who have a profound sensorineural hearing loss in one ear and
- •normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air
- •conduction (AC) threshold of the hearing ear should then be better than or
- •equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz)
- •3.3.OR subjects who are indicated for an air-conduction contralateral routing
- •of signals (AC CROS) hearing aid, but who for some reason cannot or will not
- •use an AC CROS.
- •4.Fluent in local language
- •5.Subjects who have the ability and are willing to follow investigational
- •procedures/requirements, e.g. to complete quality of life scales.
- •MRI sub-study
- •- Enrolled in the BC101 clinical investigation.
- •- Signed informed consent for the MRI sub-study.
- •- Minimum 6 weeks post-surgery.
排除标准
- •1.Inability to undergo general or local anaesthesia
- •2.Prior implantation with percutaneous device or middle ear implant on the side
- •to be implanted
- •3.Known medical conditions that contraindicate undergoing surgery as judged by
- •the investigator
- •4.Untreated ongoing middle ear infection at the time of surgery
- •5.Known insufficient bone quality/quantity/depth or skull size (scull
- •abnormalities) for implantation of a Sentio Ti Implant
- •6.Known or suspected contact allergy to silicone or other material used in the
- •Sentio system.
- •7.Known condition that could jeopardize wound healing and skin condition e.g.
- •uncontrolled diabetes over time as judged by the investigator.
- •8.Known skin or scalp conditions that may preclude attachment or interfere with
- •the usage of the SP.
- •9.Known retro cochlear pathology and auditory processing disorders that may
- •have an impact on the outcome of the investigation
- •10.Any other known condition that the investigator determines could interfere
- •with compliance or investigation assessments.
- •11.Use of ototoxic drugs that could be harmful to the hearing, as judged by the
- •investigator.
- •12.Subject that has received radiotherapy in the area of implantation or is
- •planned for such radiotherapy or similar during the investigation period.
- •13.For bilateral asymmetric candidates, subject already treated with a
- •bone-anchored hearing solution on the side with the best BC thresholds
- •14.Known chronic or non-revisable vestibular or balance disorder
- •15.Known abnormally progressive hearing loss
- •16.For conductive and mixed losses: evidence that hearing loss is
- •retro-cochlear or central origin
- •17.Participation in another clinical investigation with pharmaceutical and/or
- •device which might cause interference with investigation participation.
- •18.Use of active implantable or body worn device that for medical reasons
- •cannot be removed or discontinued, such as CSF shunts, implantable cardiac
- •pacemakers, defibrillators, or neurostimulators.
- •19.Known need for frequent MRI investigations for follow-up of other diseases.
- •20.Any subject that according to the Declaration of Helsinki is deemed
- •unsuitable for investigation enrolment.
- •MRI sub-studie:
- •- Use of other implantable or bodily worn devices that cannot be removed or are
- •not MRI safe under the conditions of the MRI scan done in this sub-study.
- •- Unsuitable for MRI examination for any reason, judged by the investigator
- •and/or the radiology staff.
研究者
相似试验
招募中
不适用
A prospective, single arm, multi-center, clinical evaluation of the Ablacath* Mapping Catheter and Ablamap® System utilizing Electrographic Flow (EGF) mapping to resolve extra-pulmonary vein sources Atrial Fibrillation sources and guide ablation therapy.irregular heartrhythm10007521atrial fibrillationNL-OMON56533Cortex Inc.60
已完成
不适用
A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating the Safety and Performance of GATT-Patch for Hemostasis during Open Liver SurgeryNL-OMON50906GATT Technologies BV47
招募中
不适用
Evaluation for the clinical Performance of EarlyTect® Bladder Cancer Test for Detecting Bladder CancerSymptoms, signs and abnormal clinical and laboratory findings, NECKCT0007266Genomictree3,753
Unknown
2 期
A clinical trial to evaluate efficacy and safety of R-TPR-004 in patients with acute ischemic strokeCTRI/2013/04/003590Reliance Life Sciences Pvt Ltd40
尚未招募
Unknown
A prospective, randomized, multi-centered clinical trial to investigate the effectiveness of the digital therapeutic device 'StroKcare' for speech rehabilitation for people with post-stroke dysarthriaKCT0008505Korea Technology & Information Promotion Agency for SMEs68