Assessment of the Feasibility and Organisational Impact of a Care Pathway Incorporating the MultiSense® Medical Device for Post-operative Home Monitoring of Elderly Patients.

NCT07514286 | Recruiting

• 2 other identifiers: 2025 - 02N° IDRCB: 2025-A02326-43
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

Assessing the clinical and organisational impact of a home-based post-operative monitoring strategy incorporating the MultiSense® device involving 80 patients aged 65 years and over who have undergone major surgery.

Conditions

Average Length of Stay; Surgery

Keywords

Remote monitoring

Outcome Measures

Primary Outcomes (1)

• The percentage of patients whose care was deemed satisfactory

  The quality of surgical care will be assessed using a "textbook outcome" (TO) composed of the 2 following criteria : 1. A shorter-than-average stay (below the 75th percentile). 2. No emergency readmission or ER visit within 7 days of going home."

  7 days

Secondary Outcomes (16)

• Average length of initial hospital stay following surgery

  7 days

• Percentage of patients requiring unscheduled care related to surgery at 30 days

  30 days

• Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days

  30 days

• Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30

  30 days

• Percentage of patients with at least one grade 3 to 5 complication according to the Clavien-Dindo classification at 30 days

  30 days

Other Outcomes (2)

• Temporal distribution of complications by severity level according to the Clavien-Dindo classification between the day of surgery and day 30

  A 30-days period

• Mapping of complications according to the following classification : complications of severity 1 to 2 and complications of severity 3 or higher according to the Clavien-Dindo classification at the end of remote monitoring and at day 30

  On the 5th day and 30th day

Study Arms (1)

MS

EXPERIMENTAL

All patients will be monitored at home with the medical device MultiSense®

Device: Monitoring by MultiSense

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

MS

Eligibility Criteria

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

You may qualify if:

• Patient aged 65 or over
• Patient eligible for remote monitoring using the MultiSense® device
• No psychiatric illness that would prevent them from giving informed consent or receiving optimal treatment and follow-up care
• Subject affiliated with a health insurance scheme
• Subject able to read and understand English
• Subject who has signed an informed consent form
• Subjects indicated for scheduled surgery
• Patients indicated for scheduled surgery :
• Transverse colectomy, by laparotomy
• Hepatic laparoscopy
• Laparoscopic or laparoscopic liver surgery (code hlfc or hlfa for procedures)
• Hysterectomy
• Adnexectomy
• Parietal surgery (eventration)
• Rectal resection

You may not qualify if:

• Patients already participating in an interventional clinical trial.
• Patients subject to legal protection measures, guardianship, curatorship, or deprived of their liberty by judicial or administrative decision.
• Patients hospitalised without consent.
• Patients unable to complete a questionnaire and without a close relative to assist them in using the solution.
• Patients admitted to or residing in a health or social care facility (other than for the surgery itself).
• Persons admitted to or residing in a health or social care institution (other than for the surgery itself);
• Persons unable to give their free and informed consent.

Sponsors & Collaborators

• Rhythm Diagnostic Systems: lead

Study Sites (4)

Western Cancer Institute of Angers

Angers, 49000, France

NOT YET RECRUITING

Bergonié Insititute

Bordeaux, 33000, France

NOT YET RECRUITING

Inter-municipal Hospital Centre of Mont-de-marsan

Mont-de-Marsan, 40000, France

NOT YET RECRUITING

Western Cancer Institute of Nantes

Nantes, 44000, France

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 7, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)