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Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication (MORPHEE 2)

U

University Hospital, Strasbourg, France

Status

Completed

Conditions

Post-operative Situation

Treatments

Device: software

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 1 patient group

prototype software
Experimental group
Treatment:
Device: software

Trial contacts and locations

1

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Central trial contact

Eric NOLL, MD

Data sourced from clinicaltrials.gov

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