Primary objectives: - To collect raw measurement data of the urinary bladder region of volunteers with the early prototype of the Bladder Sensor in multiple postural positions to evaluate the detectability of the bladder in the intended users - To…
ID
Source
Brief title
Condition
- Other condition
- Urinary tract signs and symptoms
Synonym
Health condition
Only healthy adult volunteers are included.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
- Bladder detectability rate as a function of gender, BMI, age, sensor
position, posture and combinations of these variables
- Raw measurement data for the development of an algorithm to determine the
bladder filling status
Secondary outcome
Secondary endpoints:
- Evaluation of the fixation methods and device regarding user needs by the
subjects on a score
- Incidence of any adverse events (AEs) and device deficiencies; namely AEs,
Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse
Device Effects (SADE) and Unanticipated Serious Adverse Device Effects (USADE)
Background summary
The future Bladder Sensor aims to prevent urinary incontinence in adult
patients (>18 years) with spinal cord injury, spina bifida, post-surgery
urinary retention, urge incontinence, overflow incontinence and who perform
intermittent catherization. In this explorative feasibility study data from
healthy subjects that match age, BMI and sex of the intended users will be
collected with the early prototype of the Bladder Sensor.
Study objective
Primary objectives:
- To collect raw measurement data of the urinary bladder region of volunteers
with the early prototype of the Bladder Sensor in multiple postural positions
to evaluate the detectability of the bladder in the intended users
- To determine the position criteria for the (future) ultrasound sensor on the
lower abdomen.
Secondary objectives:
- To collect data on the skin-friendly adhesive and supportive belt used to fix
the transducer assembly to the lower abdomen by the subject.
- To document adverse events and device deficiencies; AEs, ADEs, SAEs, SADEs
and DDs.
Study design
This clinical investigation is designed according to the ISO 14155:2020 as
follows:
explorative
prospective
monocentric
non-randomized
single-arm with healthy subjects
uncontrolled
open-label
feasibility study using the early prototype of the Bladder Sensor.
Intervention
The early prototype of the Bladder Sensor will be tested by healthy volunteers,
who would not test this device otherwise.
Study burden and risks
There are no direct and primary anticipated clinical benefits of the early
prototype of the Bladder Sensor for the participating subjects, as they are
healthy volunteers. However, results of this explorative feasibility study will
be crucial for the Sponsor to optimize the product development process for this
newly developed Bladder Sensor. The results will be used to, first, verify if
the chosen hardware is sufficient (in terms of signal level, field of view,
etc.) to achieve the intended functionality of the future device, second,
develop criteria for positioning of the device, third, develop an algorithm to
estimate the bladder filling status and, forth, gain insight regarding user
needs focusing on fixation method and device among healthy subjects.
Mölndals bro 2
Gothenburg SE-405 03
SE
Mölndals bro 2
Gothenburg SE-405 03
SE
Listed location countries
Age
Inclusion criteria
1) Men, women and diverse * 35 and <75 years old
2) Capability to understand the subject information and to provide conscious
informed consent
3) Signed informed consent for study participation and data protection
regulations
4) All subjects with childbearing potential must either be surgically sterile
(hysterectomy or tubal ligation) or agree to use a reliable method of
contraception with a failure rate of a Pearl-Index less than 1% per year when
used consistently and correctly such as implants, injectables, combined oral
contraceptives, some intra uterine devices, sexual abstinence or vasectomized
partner for at least 4 weeks
5) Willingness to conduct a urine pregnancy test for all subjects with
childbearing potential
6) BMI *18.5 kg/m² and <40 kg/m²
7) Capability and willingness to follow the following requirements: protocol,
current hygiene concept and laboratory safety
Exclusion criteria
1) Subjects with urological problems or lower urinary tract symptoms
2) Subjects with breached skin, open wounds, sutures or major scar tissue in
the suprapubic region.
3) Subjects with active implants that can be affected by electromagnetic
interference (e.g. pacemaker)
4) Subjects with symptoms of constipation or diarrhea
5) Subjects who are pregnant or breast feeding
6) Known allergies or intolerances to one or several components of the study
product
7) 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 / study
personnel
8) 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 / study
personnel
9) 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*
10) Participation in any clinical investigation with systemic and/or
pharmaceutical substances within the last 4 weeks and/or in parallel*
11) Sponsors, manufacturers or CRO staff
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04720222 |
| CCMO | NL76062.028.20 |