System ValidationNCT05454813

Wetness Sensing System

A study testing Wetness Sensing System Validation in people with System Validation, run by Medline Industries at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: System Validation
What is being tested?: Wetness Sensing System Validation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2022to 29 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals at least18 years of age
Individual can dress and undress self with no assistance
Individuals can ambulate without assistance
Individual can sit unsupported in a chair or on bedside with no assistance
Individual can lay supine and propel self up with no assistance
Individual can lie left/right lateral and propel self up with no assistance
Individuals who have hip dimensions between 32" and 70" (81-178 cm

Who cannot join

Individual is sensitive to the components of the study product(s).
Individual is considered inappropriate by the Principal Investigator (PI).
Individual has self-reported current skin condition(s) or issues around the sacral or perineal areas, such as open sores, sacral pressure injuries, rash, burns, surgical wounds and/or compromise of skin integrity.
Individuals who cannot complete all phases of the study requirements.
Individual requires use of an absorbent undergarment or catheter as the primary incontinence management strategy
Individuals who are pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Rochester Clinical Research, Inc.
Rochester, New York, 14609

Other trials in United States

About this study

Official title: Evaluation of a Wetness Sensing System for Continence Care

The investigational product to be evaluated in this study is FitRight® ConnectTM Wetness Sensing System which includes: the FitRight® ConnectTM Pod, the FitRight® ConnectTM App, the FitRight® ConnectTM charger/adapter and the FitRight® ConnectTM Sensing Brief-(Medline Industries, LP) henceforth, referred to as FitRight® System, Pod, App, Charger, Alert Indicator and Brief. The purpose of this study is to validate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (~90-360 milliliters (mL)) normal saline via simulated urinary void to trigger an alert to change the brief.

Read the detailed description

Each participant will be provided with the FitRight® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. Each participant will be asked to wear at least three briefs so that they are wearing each brief during the simulated voids performed by the site staff. The site staff will perform the simulated void by addition of (90-360 mL normal saline to the brief. The FitRight® System will be assessed for alerts while participants are in the following positions: supine, sitting, and laying on either left or right side. Each participant will be randomized to either the left or right side. Twenty-two of the fifty-six participants will perform rewet testing procedures. The study results will be used to assess the reliability of the device's absorption to trigger an alert

Conditions: System Validation
Being tested: Wetness Sensing System Validation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wetness Sensing System ValidationDevice
Participants will use the Wetness Sensing System in a simulated setting in the sitting, supine and side position (participants are randomized to either the left or right side position).

Study groups in NCT05454813
Study group	Role	What they receive
All	Other	Each participant will be provided with the FitRight ® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. Receives: Device: Wetness Sensing System Validation

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensor Detection
Evaluate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (~90-360mL) normal saline via a simulated urinary void to trigger an alert to change the brief in the sitting, supine, and right or left side positions.
Measured: 5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position).

Secondary outcomes (1)

Rewet Test
Determine the FitRight Brief's residual volume capacity. In a subset of 22 participants, evaluate the FitRight Brief after the brief has absorbed the maximum amount of liquid normal saline via a simulated urinary void (360mL) in the sitting position and then weighed via the rewet procedure.
Measured: 10 minutes after the 360 milliliters saline is poured into the brief.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202229 Jun 2022

First posted12 Jul 2022
Study start8 Jun 2022
Primary completion29 Jun 2022
Study completion29 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for System ValidationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05454813
Sponsor's protocol ID: MED-2021-DIV82-002
Status last verified: Aug 2023
First submitted: 7 Jul 2022
Last updated: 3 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Wetness Sensing System for Continence Care
ClinicalTrials.gov ID: NCT05454813
Acronym / sponsor ID: MED-2021-DIV82-002
Conditions: System Validation
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Medline IndustriesIndustry (pharma, biotech, devices)
Collaborators: Rochester Clinical Research
Study start: 8 Jun 2022 (actual)
Primary completion: 29 Jun 2022 (actual)
Study completion: 29 Jun 2022 (actual)
First posted: 12 Jul 2022 (actual)
Results: Posted 15 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All	Other	Device: Wetness Sensing System ValidationEach participant will be provided with the FitRight ® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Individuals at least18 years of age
Individual can dress and undress self with no assistance
Individuals can ambulate without assistance
Individual can sit unsupported in a chair or on bedside with no assistance
Individual can lay supine and propel self up with no assistance

Key exclusion criteria (6 listed)

Individual is sensitive to the components of the study product(s).
Individual is considered inappropriate by the Principal Investigator (PI).
Individual has self-reported current skin condition(s) or issues around the sacral or perineal areas, such as open sores, sacral pressure injuries, rash, burns, surgical wounds and/or compromise of skin integrity.
Individuals who cannot complete all phases of the study requirements.
Individual requires use of an absorbent undergarment or catheter as the primary incontinence management strategy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Wetness Sensing System ValidationParticipants will use the Wetness Sensing System in a simulated setting in the sitting, supine and side position (participants are randomized to either the left or right side position).	Device	All

Primary outcome

Sensor Detection
Time frame: 5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position).
Evaluate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (~90-360mL) normal saline via a simulated urinary void to trigger an alert to change the brief in the sitting, supine, and right or left side positions.

1 secondary outcome

Rewet Test
Time frame: 10 minutes after the 360 milliliters saline is poured into the brief.

Results and safety

Results posted to the registry on 15 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	56	56

Primary outcome: Sensor Detection

Time frame: 5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position).. Mean (95% Confidence Interval). Unit: percentage of passes

Measure	All Participants n = 52
Value	96.15 (0 to 100)

Population analysed: Four participants were removed from the analysis because of deviations. The measure type mean was chosen below because the unit of measure is the percentage of passes.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 56 (0%)	0 of 56 (0%)	0 of 56

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julie Miller study director

Medline Industries

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wetness Sensing System Validation in people with System Validation, run by Medline Industries at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensor Detection (time frame: 5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05454813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.