Post-operative SituationMORPHEE 2NCT05707247
Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication
A study testing software in people with Post-operative Situation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Situation
- What is being tested?
- software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2023to 4 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Feasibility of an Expert Decision Support System for Patients Regarding the Optimization of the Management of Drugs With Conditional Administration in the Surgical Department: Pilot Study
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.
- Conditions
- Post-operative Situation
- Being tested
- software
- Keywords
- prototype software, patient interface, experimental medical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
softwareDevice
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
| Study group | Role | What they receive |
|---|---|---|
| prototype software | Experimental | Not described Receives: Device: software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Recommendation pairs were analyzed in this Outcome Measure for the number of recommendation pairs that matched recommendations between the INSAMED Computer Tool and the Healthcare Professional,
The recommendations of the INSAMED computer tool will be collected by extracting the history from the digital interface (commercial smartphone) hosting the expert system.
The recommendations established by a caregiver from the research team based on a best practice algorithm will be determined: After receiving the device activation message, a caregiver (registered nurse) from the research team will establish a recommendation based on the medical algorithm for treating the symptom, medical prescriptions and the patient's interview without consulting INSAMED. The response provided by the nurse in charge of the patient is not used as the gold standard because, in practice, the responses provided may differ from the medical ideal (e.g. unavailability of staff or non-compliance with the care plan).
Measured: Day 2 post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start13 Feb 2023
- Primary completion28 Jun 2023
- Study completion4 Jul 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative SituationStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric NOLL, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707247
- Sponsor's protocol ID
- 8706
- Acronym
- MORPHEE 2
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2023
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Noll E, Noll-Burgin M, Bonnomet F, Reiter-Schatz A, Gourieux B, Bennett-Guerrero E, Goetsch T, Meyer N, Pottecher J. Knowledge-based, computerized, patient clinical decision support system for perioperative pain, nausea and constipation management: a clinical feasibility study. J Clin Monit Comput. 2024 Aug;38(4):907-913. doi: 10.1007/s10877-024-01148-z. Epub 2024 Apr 12.
PubMed 38609723
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of an Expert Decision Support System for Patients Regarding the Optimization of the Management of Drugs With Conditional Administration in the Surgical Department: Pilot Study
- ClinicalTrials.gov ID
- NCT05707247
- Acronym / sponsor ID
- MORPHEE 2 / 8706
- Conditions
- Post-operative Situation
- Keywords
- prototype software, patient interface, experimental medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Posted 14 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prototype software | Experimental | Device: software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| softwareThe 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 | Device | prototype software |
Primary outcome
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.
Time frame: Day 2 post operative
Recommendation pairs were analyzed in this Outcome Measure for the number of recommendation pairs that matched recommendations between the INSAMED Computer Tool and the Healthcare Professional, The recommendations of the INSAMED computer tool will be collected by extracting the history from the digital interface (commercial smartphone) hosting the expert system. The recommendations established by a caregiver from the research team based on a best practice algorithm will be determined: After receiving the device activation message, a caregiver (registered nurse) from the research team will establish a recommendation based on the medical algorithm for treating the symptom, medical prescriptions and the patient's interview without consulting INSAMED. The response provided by the nurse in charge of the patient is not used as the gold standard because, in practice, the responses provided may differ from the medical ideal (e.g. unavailability of staff or non-compliance with the care plan).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38609723Noll E, Noll-Burgin M, Bonnomet F, Reiter-Schatz A, Gourieux B, Bennett-Guerrero E, Goetsch T, Meyer N, Pottecher J. Knowledge-based, computerized, patient clinical decision support system for perioperative pain, nausea and constipation management: a clinical feasibility study. J Clin Monit Comput. 2024 Aug;38(4):907-913. doi: 10.1007/s10877-024-01148-z. Epub 2024 Apr 12.
Related trials for Post-operative Situation
Not yet recruiting
PROMs-guided Perioperative Care in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial
Postoperative Follow-up
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.
Eric NOLL, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing software in people with Post-operative Situation, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 4 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 14 Apr 2026. 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 France. 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 14 Apr 2026). 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?
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. (time frame: Day 2 post operative). 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 NCT05707247, which also lists 1 linked publication.
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 14 Apr 2026.