A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use

Laborie Medical Technologies

Status: Completed

Conditions: Urology

Treatments: Device: Peritron+

Study type: Interventional

Funder types: Industry

Identifiers

NCT02746406

PLUS-HF-01

Details and patient eligibility

About

In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry method. In the home setting a human factor/usability study will be conducted to measure the subject's ability to perform a successful SMIP assessment at full and empty bladder with the Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean intermittent catheter (CIC).

Enrollment: 5 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children (2 to 18 years old)
• Subjects who perform CIC regularly
• Must be able to understand English instructions (written or oral)

Exclusion criteria

• Subjects suffering from symptomatic bladder infection

Trial design

5 participants in 1 patient group

Peritron+

Experimental group

Description:

SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter

Treatment:

Device: Peritron+