An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.
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.
Rhythm Diagnostic Systems
490 participants
Jun 16, 2026
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria9
- 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 Criteria5
- 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
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Interventions
The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07552805