Reduction in the Initial Length of StaySENSE-ECONCT07552805
An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.
A study testing Monitoring by MultiSense® in people with Reduction in the Initial Length of Stay, run by Rhythm Diagnostic Systems at 9 sites in France.
Trial summary
The SENSE-ECO study is a prospective, randomized trial of 490 high-risk patients designed to show that the MultiSense® remote monitoring patch safely reduces hospital stays following major digestive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction in the Initial Length of Stay
- What is being tested?
- Monitoring by MultiSense®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 9 sitesFrance
- Study dates
- 16 Jun 2026to 16 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (aged 18 and over)
- Patients scheduled for gastrointestinal surgery :
- Major gastrointestinal cancer surgery (pancreas, liver, stomach, oesophagus, rectum)
- Colorectal surgery (rectal resection, surgery on the rectum and anus other than rectal resection, minor or major surgery on the small intestine and colon)
- Patients in non-critical care with a high risk of post-surgical complications (ASA score 2 or 3)
- Patients who have a personal mobile phone and Wi-Fi connectivity at home
Show all 9Show fewer
- Patients who provide written informed consent to participate in the study
- Patients who are members of or beneficiaries of a social security scheme
- Patients who are proficient in French
Who cannot join
- Patients with a contraindication to the use of the device as described in the instructions for use (in particular: known skin allergy to adhesives or silicone, active implantable medical device such as a pacemaker or defibrillator, need for an MRI scan during the intended use of the device, intended application site of the device being tattooed, infected, ulcerated or damaged)
- Any other condition which, in the investigator's opinion, would compromise the patient's safety or prevent compliance with the requirements of the protocol
- Pregnant or breastfeeding patient
- Adult under legal protection (under guardianship, curatorship or judicial protection)
- Patient already participating in a clinical trial
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
CHU Amiens-Picardie
Amiens, 80000
Pr Jean-Marc REGIMBEAU, Visceral and digestive surgeon, +33 3 22 08 88 93, regimbeau.jean-marc@chu-amiens.fr
- Not yet recruiting
CHU de Besançon
Besançon, Doubs, 25000
Alexandre Pr Alexandre DOUSSOT, Visceral and digestive surgeon, + 33 3 81 66 83 43, adoussot@chu-besancon.fr
- Not yet recruiting
GHND
Bourgoin, Isère, 38302
Pierre Dr Pierre GOUBAULT, Visceral and digestive surgeon, +33 4 69 15 72 06, pierre.goubault@ghnd.fr
- Not yet recruiting
CHU de Nice
Nice, Alpes-Maritimes, 06000
Damien Dr Damien MASSALOU, Visceral and digestive surgeon, +33 4 92 03 92 64, massalou.d@chu-nice.fr
- Recruiting
Hôpital Cochin, AP-HP Centre
Paris, 75014
Dr Ugo MARCHESE, Visceral and digestive surgeon, +33 1 58 41 39 08, ugo.marchese@aphp.fr
- Not yet recruiting
CHU Reims
Reims, Grand Est, 51100
Sophie Pr Sophie DEGUELTE, Visceral and digestive surgeon, +33 3 26 78 71 21, sdeguelte@chu-reims.fr
- Not yet recruiting
La Sagesse Mutualist Clinic
Rennes, Brittany Region, 35000
Damien Dr Damien BERGEAT, Visceral and digestive surgeon, +332 99 85 75 30, damien.bergeat@hospigrandouest.fr
- Not yet recruiting
CHU Charles-Nicolle
Rouen, Seine-Maritime, 76000
Valérie Dr Valérie BRIDOUX, Gastrointestinal surgeon, +33 2 32 88 81 42, valerie.bridoux@chu-rouen.fr
- Not yet recruiting
CHU Saint-étienne
Saint-Etienne, Auvergne-Rhône-Alpes, 42000
Bertrand Dr Bertrand LE ROY, +33 4 77 12 77 17, bertrand.leroy@chu-st-etienne.fr
About this study
Official title: Clinical and Health Economic Evaluation of the Multisense® Solution: Ensuring a Safe Return Home for Patients at High Risk of Complications Following Gastrointestinal Surgery, Compared With the Standard Care Pathway.
The SENSE-ECO study is a prospective, randomized trial of 490 high-risk patients designed to show that the MultiSense® remote monitoring patch safely reduces hospital stays following major digestive surgery. By continuously tracking vital signs for five days at home, the device aims to maintain clinical safety and quality of life while decreasing overall healthcare costs for the French medical system.
Read the detailed description
SENSE-ECO study is a prospective, multicenter, randomized open-label trial designed to evaluate the clinical and medico-economic impact of the MultiSense® remote monitoring solution for 490 high-risk patients (ASA 2 or 3) undergoing major digestive surgery. The primary objective is to demonstrate that using this Class IIa wearable patch to monitor vital signs-such as heart rate, $SpO_2$, and respiratory rate-allows for a reduced initial hospital stay without increasing 30-day morbidity compared to standard care. In the experimental group, patients are equipped with the device 12 to 24 hours before discharge to continue continuous home monitoring for five days, while the study also assesses secondary factors including cost-effectiveness for the French healthcare system, patient quality of life via the fQoR-15 questionnaire, and organizational workload for medical staff. Conducted across five centers under the coordination of Dr. Ugo Marchese.
- Conditions
- Reduction in the Initial Length of Stay
- Being tested
- Monitoring by MultiSense®
- Keywords
- Remote monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring by MultiSense®Device
The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters
| Study group | Role | What they receive |
|---|---|---|
| MultiSense® group | Experimental | Patients wearing the multisense® patch Receives: Device: Monitoring by MultiSense® |
| Standard group | No intervention | Patients following the standard care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean CCI score of the Detailed Complications Index, calculated on the basis of complications recorded according to the Clavien-Dindo classification over a 30 day postoperative period for each of the two groups: the MultiSense group and Standard group
The Clavien-Dindo classification is a system used in surgery to classify postoperative complications according to their severity
Measured: 30 days
The average length of the initial stay for both groups
Measured: Up to 30 days
Secondary outcomes (13)
Average CCI score from the Detailed Complications Index, calculated based on complications recorded according to the Clavien-Dindo classification over 8days, 15days, 30days and 90days post-surgery for each of the two groups: MultiSense® grp & Standad grp
Secondary "clinical" outcome measures
Measured: 8days, 15days, 30days and 90days
Average number of deaths in each arm over 8 days, 15 days, 30 days and 90 days
Secondary "clinical" outcome measures
Measured: 8 days, 15 days, 30 days and 90 days
Average total cumulative length of stay over 30 days
Secondary "clinical" outcome measures
Measured: 30 days
Average number of hospital readmissions among patients receiving MultiSense® compared with patients receiving standard care, over a 30 days period; severity of the patient at readmission assessed using the Clavien-Dindo classification
Secondary "clinical" outcome measures
Measured: 30 days
Patient quality of life scores assessed at baseline, on discharge from hospital and at 30 days using the fQoR-15 questionnaire
Secondary "clinical" outcome measures Assess the impact on patient's quality of life fQoR-15 : French Quality of Recovery-15 15 : corresponds to the 15 multidimensional questions that make up the score. The total score ranges from 0 to 150 The higher the score, the better the quality of post-operative recovery High score = optimal recovery Low score = impaired recovery
Measured: 30 days
Total 30-day healthcare costs (€) and cost-effectiveness comparing outcome differences between groups, including morbidity, length of stay, readmissions, patient severity, staff satisfaction, quality of life, and organisational impact.
Secondary "medico-economic" outcome measures
Measured: 30 days
Net benefit to the healthcare system (€) from the roll-out of the Multisense solution in France (difference between incurred and avoided costs) over 4 years
Secondary "medico-economic" outcome measures
Measured: 4 years
Average daily time (hours and minutes) spent on the platform by the remote monitoring team to monitor patients in the MultiSense group (collected via the MultiSense platform)
Secondary "organisational impact" outcome measures
Measured: Daily during the 5 days remote monitoring period following hospital discharge
Average number of incoming and outgoing calls per patient in both groups within 30 days of surgery
Secondary "organisational impact" outcome measures
Measured: 30 days
Table of activities and stakeholders enabling a comprehensive identification of the roles of the various parties involved in post-operative monitoring within each group
Secondary "organisational impact" outcome measures
Measured: Up to 30 days post-surgery
Levels of satisfaction 30 days post-operation, as reported by healthcare professionals (surgeons and paramedical staff involved in patient follow-up) and by patients, assessed using ad hoc questionnaires designed for the study
Secondary "organisational impact" outcome measures
Measured: 30 day
Assessment of the usability of the MultiSense® solution for healthcare professionals involved in post-operative follow-up, using the F-SUS scale completed at the end of the study
Secondary organisational impact outcome measures F-SUS : French version of the System Usability Scale Minimum value : 0 Maximum value : 100
Interpretation of the score :
A high score indicates a positive result. The closer the score is to 100, the more the system (in this case, the MultiSense® solution) is considered to be user-friendly, intuitive and satisfactory for healthcare professionals. Conversely, a low score indicates poor usability.
Measured: 18 months
Percentage of patients non-compliant with remote monitoring via MultiSense® (non-compliance is defined as discontinuation of monitoring before 80% of the scheduled duration has elapsed, which corresponds to the fourth day)
Secondary "organisational impact" outcome measures
Measured: 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start16 Jun 2026
- Primary completion16 Sep 2028 (estimated)
- Study completion16 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction in the Initial Length of StayStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 490 patients in total : 245 patients will wear the multisense patch and 245 will receive standard care
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhythm Diagnostic Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Calypse, BPIfrance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552805
- Sponsor's protocol ID
- 2025 - 01
- Acronym
- SENSE-ECO
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Health Economic Evaluation of the Multisense® Solution: Ensuring a Safe Return Home for Patients at High Risk of Complications Following Gastrointestinal Surgery, Compared With the Standard Care Pathway.
- ClinicalTrials.gov ID
- NCT07552805
- Acronym / sponsor ID
- SENSE-ECO / 2025 - 01
- Conditions
- Reduction in the Initial Length of Stay
- Keywords
- Remote monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Rhythm Diagnostic SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Calypse, BPIfrance
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 16 Sep 2028 (estimated)
- Study completion
- 16 Feb 2029 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SENSE-ECO study is a prospective, randomized trial of 490 high-risk patients designed to show that the MultiSense® remote monitoring patch safely reduces hospital stays following major digestive surgery. By continuously tracking vital signs for five days at home, the device aims to maintain clinical safety and quality of life while decreasing overall healthcare costs for the French medical system.
Detailed description
SENSE-ECO study is a prospective, multicenter, randomized open-label trial designed to evaluate the clinical and medico-economic impact of the MultiSense® remote monitoring solution for 490 high-risk patients (ASA 2 or 3) undergoing major digestive surgery. The primary objective is to demonstrate that using this Class IIa wearable patch to monitor vital signs-such as heart rate, $SpO_2$, and respiratory rate-allows for a reduced initial hospital stay without increasing 30-day morbidity compared to standard care. In the experimental group, patients are equipped with the device 12 to 24 hours before discharge to continue continuous home monitoring for five days, while the study also assesses secondary factors including cost-effectiveness for the French healthcare system, patient quality of life via the fQoR-15 questionnaire, and organizational workload for medical staff. Conducted across five centers under the coordination of Dr. Ugo Marchese.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 490 patients in total : 245 patients will wear the multisense patch and 245 will receive standard care
| Arm | Type | Receives |
|---|---|---|
| MultiSense® group | Experimental | Device: Monitoring by MultiSense®Patients wearing the multisense® patch |
| Standard group | No intervention | –Patients following the standard care pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults (aged 18 and over)
- Patients scheduled for gastrointestinal surgery :
- Major gastrointestinal cancer surgery (pancreas, liver, stomach, oesophagus, rectum)
- Colorectal surgery (rectal resection, surgery on the rectum and anus other than rectal resection, minor or major surgery on the small intestine and colon)
- Patients in non-critical care with a high risk of post-surgical complications (ASA score 2 or 3)
Key exclusion criteria (5 listed)
- Patients with a contraindication to the use of the device as described in the instructions for use (in particular: known skin allergy to adhesives or silicone, active implantable medical device such as a pacemaker or defibrillator, need for an MRI scan during the intended use of the device, intended application site of the device being tattooed, infected, ulcerated or damaged)
- Any other condition which, in the investigator's opinion, would compromise the patient's safety or prevent compliance with the requirements of the protocol
- Pregnant or breastfeeding patient
- Adult under legal protection (under guardianship, curatorship or judicial protection)
- Patient already participating in a clinical trial
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 |
|---|---|---|
| Monitoring by MultiSense®The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters | Device | MultiSense® group |
Primary outcome
Mean CCI score of the Detailed Complications Index, calculated on the basis of complications recorded according to the Clavien-Dindo classification over a 30 day postoperative period for each of the two groups: the MultiSense group and Standard group
Time frame: 30 days
The Clavien-Dindo classification is a system used in surgery to classify postoperative complications according to their severity
The average length of the initial stay for both groups
Time frame: Up to 30 days
13 secondary outcomes
Average CCI score from the Detailed Complications Index, calculated based on complications recorded according to the Clavien-Dindo classification over 8days, 15days, 30days and 90days post-surgery for each of the two groups: MultiSense® grp & Standad grp
Time frame: 8days, 15days, 30days and 90days
Average number of deaths in each arm over 8 days, 15 days, 30 days and 90 days
Time frame: 8 days, 15 days, 30 days and 90 days
Average total cumulative length of stay over 30 days
Time frame: 30 days
Average number of hospital readmissions among patients receiving MultiSense® compared with patients receiving standard care, over a 30 days period; severity of the patient at readmission assessed using the Clavien-Dindo classification
Time frame: 30 days
Patient quality of life scores assessed at baseline, on discharge from hospital and at 30 days using the fQoR-15 questionnaire
Time frame: 30 days
Total 30-day healthcare costs (€) and cost-effectiveness comparing outcome differences between groups, including morbidity, length of stay, readmissions, patient severity, staff satisfaction, quality of life, and organisational impact.
Time frame: 30 days
Net benefit to the healthcare system (€) from the roll-out of the Multisense solution in France (difference between incurred and avoided costs) over 4 years
Time frame: 4 years
Average daily time (hours and minutes) spent on the platform by the remote monitoring team to monitor patients in the MultiSense group (collected via the MultiSense platform)
Time frame: Daily during the 5 days remote monitoring period following hospital discharge
Average number of incoming and outgoing calls per patient in both groups within 30 days of surgery
Time frame: 30 days
Table of activities and stakeholders enabling a comprehensive identification of the roles of the various parties involved in post-operative monitoring within each group
Time frame: Up to 30 days post-surgery
Levels of satisfaction 30 days post-operation, as reported by healthcare professionals (surgeons and paramedical staff involved in patient follow-up) and by patients, assessed using ad hoc questionnaires designed for the study
Time frame: 30 day
Assessment of the usability of the MultiSense® solution for healthcare professionals involved in post-operative follow-up, using the F-SUS scale completed at the end of the study
Time frame: 18 months
Percentage of patients non-compliant with remote monitoring via MultiSense® (non-compliance is defined as discontinuation of monitoring before 80% of the scheduled duration has elapsed, which corresponds to the fourth day)
Time frame: 4th day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring by MultiSense® in people with Reduction in the Initial Length of Stay, run by Rhythm Diagnostic Systems at 9 sites 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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean CCI score of the Detailed Complications Index, calculated on the basis of complications recorded according to the Clavien-Dindo classification over a 30 day postoperative period for each of the two groups: the MultiSense group and Standard group (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.