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Clinical Trials/NL-OMON50868
NL-OMON50868
Completed
Not Applicable

An explorative, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early TENA Bladder Sensor prototype - Detectability of the bladder with an early prototype of the Bladder Sensor

Essity Hygiene and Health AB0 sites84 target enrollmentTBD
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ConditionsOnly healthy adult volunteers are included.Involuntarily urine loss10046590

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Only healthy adult volunteers are included.
Sponsor
Essity Hygiene and Health AB
Enrollment
84
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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

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
  • •7\) Alcohol abuse as\*reported\*by subject and/ or suspected by investigator that
  • •impacts capability to understand the subject information and to provide

Outcomes

Primary Outcomes

Not specified

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