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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRhythm Diagnostic Systems

About this trial

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 criteria

Qualifiers

Adults (aged 18 and over)

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Monitoring by MultiSense®

Treatment groups

490 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rhythm Diagnostic Systems

Lead sponsor

Calypse

Collaborator

BPIfrance

Collaborator