An Explorative, Single-center, Feasibility Study to Collect Data for the Continuous Development of the Future Bladder Sensor Algorithm in Adults During Urodynamics
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Raw measurement data for the development of an algorithm to determine the bladder filling status
研究概览
简要总结
This is an explorative, single-center, feasibility study using a prototype of a future Bladder Sensor to collect data during urodynamics. Obtained data shall be used for the continuous development of the future Bladder Sensor, which is intended for use for individuals suffering from urinary incontinence.
详细描述
The purpose of this clinical investigation is to collect raw measurement data of the urinary bladder region of participants (patients who are scheduled for urodynamics and fulfill the in- and exclusion criteria) with the TENA-PROTO2, for the continuous development of an algorithm to determine the bladder filling status with the future Bladder Sensor. Secondarily, safety of the subjects will be continuously documented such as adverse events (AE) and device deficiencies (DD); AEs, Adverse Device Events (ADE), Severe Adverse Events (SAE), Severe Adverse Device effects (SADE), Unanticipated Serious Adverse Device Effects (USADE) and DDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are scheduled for urodynamics
- •Men and women defined by biological sex at birth
- •Individuals at the age of ≥ 18 years
- •BMI >18.5 kg/m² and ≤ 39.9 kg/m²
- •Capability to understand the subject information and to provide conscious informed consent
- •Signed informed consent for study participation and data protection regulations
- •Willingness to conduct a urine pregnancy test for all female subjects <55 years old (Exceptions: the site team determines that the subject is not likely to become pregnant due to e.g., hysterectomy, postmenopausal)
- •Capability and willingness to follow the study protocol and procedure of the urodynamics
排除标准
- •Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region
- •Subjects with suprapubic catheter
- •Subjects with implants that can be affected by electromagnetic interference (e.g. pacemaker)
- •Subjects who are pregnant or breast feeding
- •Known allergies or intolerances to one or several components of the study product
- •Alcohol abuse as reported by subject and/ or suspected by investigator that impacts capability to understand the subject information and to provide conscious informed consent in the discretion of the investigator
- •Drug abuse as reported by subject and/ or suspected by investigator that impacts capability to understand the subject information and to provide conscious informed consent in the discretion of the investigator
- •Objections of the investigator to the subject's participation in the trial due to medical reasons or any other reason for which the subject should not participate in the opinion of the investigator
- •Participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel
- •Sponsors, manufacturers or clinical research organization (CRO) staff
研究组 & 干预措施
TENA-PROTO2
Investigational device. Late prototype
干预措施: TENA-PROTO2 (Device)
结局指标
主要结局
Raw measurement data for the development of an algorithm to determine the bladder filling status
时间窗: 4 months
Raw data that has been assessed by the prototype (TENA-PROTO2) will be used to develop a product specific algorithm (R\&D outcome) for the future Bladder sensor.
次要结局
- Any adverse event (AE) or device deficiency (DD)(Ongoing documentation after enrolment until end of the measurement day (4 months))