An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.
Condition(s) studied
Investigational drug(s) / intervention(s)
Monitoring by MultiSense®: The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters
Study 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
Primary outcome measure(s)
- 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 — 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 — Up to 30 days
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Nice | Nice | Alpes-Maritimes | Not Yet Recruiting |
| CHU Saint-étienne | Saint-Etienne | Auvergne-Rhône-Alpes | Not Yet Recruiting |
| La Sagesse Mutualist Clinic | Rennes | Brittany Region | Not Yet Recruiting |
| CHU de Besançon | Besançon | Doubs | Not Yet Recruiting |
| CHU Reims | Reims | Grand Est | Not Yet Recruiting |
| GHND | Bourgoin | Isère | Not Yet Recruiting |
| CHU Charles-Nicolle | Rouen | Seine-Maritime | Not Yet Recruiting |
| CHU Amiens-Picardie | Amiens | France | Not Yet Recruiting |
| Hôpital Cochin, AP-HP Centre | Paris | France | Recruiting |
More Rhythm Diagnostic Systems trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07552805 on ClinicalTrials.gov ↗ ← All trials in France