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Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.

NCT06092099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

TENA SmartCare Change Indicator

The TENA SmartCare Change Indicator is an accessory to absorbent incontinence products, intended for use on individual(s) with urinary incontinence who are dependent on one or more caregivers to change the absorbent incontinence product. The TENA SmartCare Change Indicator estimates the degree of urine saturation in the absorbent incontinence product and notifies the caregivers. This facilitates the caregiver's decision regarding when to change the absorbent incontinence product. As the current study is needed to validate the updated device, the full system will not be used, only the sensor part.

Sponsors & Collaborators

  • Essity Hygiene and Health AB

    lead INDUSTRY

Principal Investigators

  • Roland Frösing, MD · VIP Hälsan Väst

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2023-12-21
Completion
2024-02-28

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06092099 on ClinicalTrials.gov