Status:
COMPLETED
Detectability of the Bladder With an Early Prototype of the Bladder Sensor
Lead Sponsor:
Essity Hygiene and Health AB
Conditions:
Urinary Incontinence
Eligibility:
All Genders
35-74 years
Phase:
NA
Brief Summary
This is an explorative, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early prototype of a future bladder sensor, wh...
Detailed Description
The purpose of this clinical investigation with healthy subjects (defined as subjects without urological problems or lower urinary tract symptoms, assured by pre-defined inclusion and exclusion criter...
Eligibility Criteria
Inclusion
- Men, women and diverse ≥ 35 and \<75 years old
- Capability to understand the subject information and to provide conscious informed consent
- Signed informed consent for study participation and data protection regulations
- 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
- Willingness to conduct a urine pregnancy test for all subjects with childbearing potential
- BMI ≥18.5 kg/m² and \<40 kg/m²
- Capability and willingness to follow the following requirements: protocol, current hygiene concept and laboratory safety
Exclusion
- Subjects with urological problems or lower urinary tract symptoms
- Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region.
- Subjects with active implants that can be affected by electromagnetic interference (e.g. pacemaker)
- Subjects with symptoms of constipation or diarrhea
- 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 / study personnel
- 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
- 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 CRO staff
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2021
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04720222
Start Date
April 29 2021
End Date
October 19 2021
Last Update
November 24 2021
Active Locations (1)
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1
Novioscan - an Essity company
Nijmegen, Netherlands, 6534AT