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

RecruitingNAAges 18 Years - anyAllRhythm Diagnostic Systems
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Monitoring by MultiSense®
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Where

9 sites
CHU de Nice
Nice, France
CHU Saint-étienne
Saint-Etienne, France
La Sagesse Mutualist Clinic
Rennes, France
CHU de Besançon
Besançon, France
CHU Reims
Reims, France
GHND
Bourgoin, France
CHU Charles-Nicolle
Rouen, France
CHU Amiens-Picardie
Amiens, France

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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