CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
TENA SmartCare Change Indicatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04071301
NCT04071301N/ACompleted
CompareCT.gov

An Explorative, Open, Single-arm Clinical Investigation to Collect Real-life Measurement Data in Order to Assess the Mathematical Algorithms Involved in TENA SmartCare Change Indicator.

Essity Hygiene and Health AB·interventional·Posted Aug 28, 2019·Updated Jun 2, 2021

In Brief

A clinical study evaluating TENA SmartCare Change Indicator for Urinary Incontinence. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 28, 2019
Enrollment StartSep 5, 2019
Primary CompletionNov 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.8 years ago

Interventions

TENA SmartCare Change Indicatordevice

Each participating subject will be provided with a Change Indicator and absorbent products for the duration of the investigation. Nine types of absorbent products will be used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject will be allocated to the type(s) that are considered most suitable. Gateways will be placed in the resident's rooms as well as in common areas, this to enable full measurement registration.