Study of Pant Type Absorbing Urinary Incontinence Products

NCT05031442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-11-24

No results posted yet for this study

Summary

Pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population

Conditions

Interventions

DEVICE

RH1 (low waist)

Investigational product variant 1 low waist

DEVICE

Reference variant 1 (low waist)

Reference product variant 1

DEVICE

RC2 (high waist)

Investigational product variant 2 high waist

DEVICE

Reference variant 2 (high waist)

Reference product variant 2

Sponsors & Collaborators

  • Essity Hygiene and Health AB

    lead INDUSTRY

Principal Investigators

  • Nathalie Paquet Labertrande, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2021-10-19
Completion
2021-11-12

Countries

  • France

Study Locations

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Entities

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 NCT05031442 on ClinicalTrials.gov