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

L

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+

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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