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

NCT07552805 | Not Yet Recruiting

• 1 other identifier: 2025 - 01
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Reduction in the Initial Length of Stay

Keywords

Remote monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

  8days, 15days, 30days and 90days

• Average number of deaths in each arm over 8 days, 15 days, 30 days and 90 days

  8 days, 15 days, 30 days and 90 days

• Average total cumulative length of stay over 30 days

  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

  30 days

• Patient quality of life scores assessed at baseline, on discharge from hospital and at 30 days using the fQoR-15 questionnaire

  30 days

Study Arms (2)

MultiSense® group

EXPERIMENTAL

Patients wearing the multisense® patch

Device: Monitoring by MultiSense®

Standard group

NO INTERVENTION

Patients following the standard care pathway

Interventions

Monitoring by MultiSense® DEVICE

The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters

MultiSense® group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhythm Diagnostic Systems: lead
• Calypse: collaborator
• BPIfrance: collaborator

Study Sites (5)

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

Location

CHU de Besançon

Besançon, Doubs, 25000, France

Location

CHU Charles-Nicolle

Rouen, Seine-Maritime, 76000, France

Location

CHU Amiens-Picardie

Amiens, 80000, France

Location

Hôpital Cochin, AP-HP Centre

Paris, 75014, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 490 patients in total : 245 patients will wear the multisense patch and 245 will receive standard care

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): September 17, 2027
• Study Completion (Estimated): November 19, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)