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Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products

NCT04846270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-04-08

Study results available
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Summary

The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.

Conditions

Interventions

DEVICE

TENA SmartCare Change Indicator

Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.

Sponsors & Collaborators

  • Essity Hygiene and Health AB

    lead INDUSTRY

Principal Investigators

  • Prof. Piotr Radziszewski, MD, PhD · Medical Concierge Centrum Medyczne, Polnej Rózy 6/U2, 02-798 Warszawa,

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2021-10-28
Completion
2021-10-28

Countries

  • Poland

Study Locations

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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 NCT04846270 on ClinicalTrials.gov