An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care. (SENSE-ECO)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Reduction in the Initial Length of Stay
• Intervention / Treatment: Device: Monitoring by MultiSense®

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 Type: Interventional
• Enrollment (Estimated): 490
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • CHU Amiens-Picardie
    • Contact: Pr Jean-Marc REGIMBEAU, Visceral and digestive surgeon; Phone Number: +33 3 22 08 88 93; Email: regimbeau.jean-marc@chu-amiens.fr
  • Paris, France, 75014
    • Hôpital Cochin, AP-HP Centre
    • Contact: Dr Ugo MARCHESE, Visceral and digestive surgeon; Phone Number: +33 1 58 41 39 08; Email: ugo.marchese@aphp.fr
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06000
      • CHU de Nice
      • Contact: Damien Dr Damien MASSALOU, Visceral and digestive surgeon; Phone Number: +33 4 92 03 92 64; Email: massalou.d@chu-nice.fr
  • Doubs
    • Besançon, Doubs, France, 25000
      • CHU de Besancon
      • Contact: Alexandre Pr Alexandre DOUSSOT, Visceral and digestive surgeon; Phone Number: + 33 3 81 66 83 43; Email: adoussot@chu-besancon.fr
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76000
      • CHU Charles-Nicolle
      • Contact: Valérie Dr Valérie BRIDOUX, Gastrointestinal surgeon; Phone Number: +33 2 32 88 81 42; Email: valerie.bridoux@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

• 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
• 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

Exclusion Criteria :

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MultiSense® group; Patients wearing the multisense® patch	Device: Monitoring by MultiSense®; The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters
No Intervention: Standard group; Patients following the standard care pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days
The average length of the initial stay for both groups		Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	8 days, 15 days, 30 days and 90 days
Average total cumulative length of stay over 30 days	Secondary "clinical" outcome measures	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	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	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	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	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	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	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	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	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.	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	4th day

Collaborators and Investigators

• Sponsor: Rhythm Diagnostic Systems
• Collaborators: BPIfrance; Calypse

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): September 17, 2027
• Study Completion (Estimated): November 19, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Remote monitoring
• Other Study ID Numbers: 2025 - 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No