NCT02746406

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 11, 2017

Completed
Last Updated

January 11, 2017

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

April 12, 2016

Results QC Date

August 2, 2016

Last Update Submit

November 15, 2016

Conditions

Urology

Outcome Measures

Primary Outcomes (1)

  • Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.

    Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group

    Through study completion, an average of 4 days

Study Arms (1)

Peritron+

EXPERIMENTAL

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

Device: Peritron+

Interventions

Peritron+DEVICE

Peritron+ device to measure intravesical pressure

Peritron+

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Subjects suffering from symptomatic bladder infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Clinical Researcher
Organization
Laborie
sbitzos@laborie.com
9056121170

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 21, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Last Updated

January 11, 2017

Results First Posted

January 11, 2017

Record last verified: 2016-09