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Studies

Interventional Recruiting

NCT07552805 on ClinicalTrials.gov

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

Official title: Clinical and Health Economic Evaluation of the Multisense® Solution: Ensuring a Safe Return Home for Patients at High Risk of Complications Following Gastrointestinal Surgery, Compared With the Standard Care Pathway.

  • Sponsor: Rhythm Diagnostic Systems
  • Collaborators: Calypse, BPIfrance
  • Enrollment: 490 (Estimated)
  • Study start: 2026-06-16 (Actual)
  • Primary completion: 2028-09-16 (Estimated)
  • Study completion: 2029-02-16 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 490 patients in total : 245 patients will wear the multisense patch and 245 will receive standard care
  • Masking: None
  • PrimaryPurpose: Other

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

Intervention / Treatment

  • Device: Monitoring by MultiSense®

Primary Outcome Measures

  • 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)

Countries

France

Locations and Investigators

  • CHU de Nice, Nice, France (Not yet recruiting)
    • Damien Dr Damien MASSALOU, Visceral and digestive surgeon
  • CHU Saint-étienne, Saint-Etienne, France (Not yet recruiting)
    • Bertrand Dr Bertrand LE ROY
  • La Sagesse Mutualist Clinic, Rennes, France (Not yet recruiting)
    • Damien Dr Damien BERGEAT, Visceral and digestive surgeon
  • CHU de Besançon, Besançon, France (Not yet recruiting)
  • CHU Reims, Reims, France (Not yet recruiting)
    • Sophie Pr Sophie DEGUELTE, Visceral and digestive surgeon
  • GHND, Bourgoin, France (Not yet recruiting)
    • Pierre Dr Pierre GOUBAULT, Visceral and digestive surgeon
  • CHU Charles-Nicolle, Rouen, France (Not yet recruiting)
  • CHU Amiens-Picardie, Amiens, France (Not yet recruiting)
  • Hôpital Cochin, AP-HP Centre, Paris, France (Recruiting)
    • Dr Ugo MARCHESE, Visceral and digestive surgeon