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Evaluation of Urine Leakage of New Absorbing Incontinence Products in a Home Care Environment

NCT05484388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-02-21

No results posted yet for this study

Summary

The aim of this interventional but non-invasive, clinical investigation is to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity.

The primary objective is to demonstrate for each of the new products that they provide protection to leakages similar to their corresponding standard of care devices already used on the market. The target population for this clinical investigation are community living individuals suffering from moderate to severe incontinence, who may receive care by a care giving relative, by one or more caregivers and are current users of TENA Pants of the respective absorption level.

Conditions

Interventions

DEVICE

SN2

Investigational device absorption level Normal

DEVICE

SP3

Investigational device absorption level Plus

Sponsors & Collaborators

  • Smerud Medical Research Germany Ltd

    collaborator UNKNOWN

  • Essity Hygiene and Health AB

    lead INDUSTRY

Principal Investigators

  • Kilian Pankert, MD · Diakonissen-Stiftungs-Krankenhaus Speyer

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2022-12-07
Completion
2023-02-03

Countries

  • Germany

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 NCT05484388 on ClinicalTrials.gov