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

• Sponsor: Laborie Medical Technologies Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02746406
• Collaborator: (none)
• Enrollment: 5
• Arm: 1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Urology	Device: Peritron+	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peritron+ SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter	Device: Peritron+; Peritron+ device to measure intravesical pressure

Outcome Measures

Primary Outcome Measures

1. 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]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Laborie Medical Technologies Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laborie Medical Technologies Inc.
• ClinicalTrials.gov Identifier: NCT02746406
• Other Study ID Numbers: PLUS-HF-01
• First Posted: Apr 21, 2016
• Last Update Posted: Jan 11, 2017
• Last Verified: Sep 1, 2016

Study Results

Participant Flow

Arm/Group Title	Peritron+
Arm/Group Description	SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter Peritron+: Peritron+ device to measure intravesical pressure
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Peritron+
Arm/Group Description	SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter Peritron+: Peritron+ device to measure intravesical pressure
Overall Participants	5
Age (Count of Participants)
<=18 years	5 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Gender (Count of Participants)
Female	2 40%
Male	3 60%
Region of Enrollment (participants) [Number]
United States	5 100%

Outcome Measures

1. Primary Outcome

Title	Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.
Description	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
Time Frame	Through study completion, an average of 4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peritron+
Arm/Group Description	SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter Peritron+: Peritron+ device to measure intravesical pressure
Measure Participants	5
Number [participants]	65 1300%

Adverse Events

Arm/Group Title	Peritron+
Arm/Group Description	SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter Peritron+: Peritron+ device to measure intravesical pressure
All Cause Mortality
	Peritron+
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Peritron+
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Peritron+
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor can review results communications prior to public release regarding trial results for a period that is less than 60 days. The sponsor can request changes to the communication.