N/A
Completed N=37
Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication
Post-operative Situation
Source: ClinicalTrials.gov NCT05707247 ↗
Enrolled (actual)
37
Serious AEs
—
Results posted
Apr 2026
Primary outcomePrimary: Rate of Agreement Between the Recommendations of the INSAMED Computer Tool and the Recommendations Made by a Healthcare Professional From the Research Team Based on the Best Practice Algorithm. — 51 recommendation pairs (Number of matches)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Agreement Between the Recommendations of the INSAMED Computer Tool and the Recommendations Made by a Healthcare Professional From the Research Team Based on the Best Practice Algorithm. |
51 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05707247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.