Study of Pant Type Absorbing Urinary Incontinence Products
NCT05031442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2021-11-24
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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