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

Urology Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02746406
• Other study ID #: PLUS-HF-01
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 12, 2016
• Last updated: April 18, 2016
• Start date: February 2016

Study information

• Verified date: April 2016
• Source: Laborie Medical Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urology

Intervention

Device:
• Peritron+
Peritron+ device to measure intravesical pressure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laborie Medical Technologies Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability Factors; simple, doable, and is comparable to the ruler-based manometry method using a questionnaire and patient diary.		Through study completion, an average of 4 days	No