Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2023-07-04

Brief Summary

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The experimental medical device is a prototype software. The device comes in the form of a smartphone with a touch interface. The smartphone used to support the software is a commercial smartphone marked CE. The study aims at assessing the feasibility of the use of this expert, patient- decision support systems.

The study hypothesis is that the clinical use of the experimental device is feasible.

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Detailed Description

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Conditions

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Post-operative Situation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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prototype software

Group Type EXPERIMENTAL

software

Intervention Type DEVICE

The experimental medical device is a prototype software. It is a patient interface.

The device comes in the form of a smartphone with a touch screen

Interventions

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software

The experimental medical device is a prototype software. It is a patient interface.

The device comes in the form of a smartphone with a touch screen

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or Female 18 years or older (no upper age limit)
* Operated within a surgical department of of the Hautepierre University Hospitals of Strasbourg
* Patient understanding and reading French
* Subject neurosensorially able of interacting with a tactile electronical interface
* Subject able to understand research objectives, risks and provide dated and signed informed consent
* Subject covered by a health insurance scheme

Exclusion Criteria

* Patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface
* Unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.)
* Pregnant or lactating woman (on declaration)
* Patient under safeguard of justice, under guardianship, under curatorship

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No