Status:
COMPLETED
Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management
Lead Sponsor:
IHU Strasbourg
Collaborating Sponsors:
Rhythm Diagnostic Systems
Conditions:
Visceral and Digestive Surgery
Post-surgical Monitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this clinical investigation, the investigators will assess the safety, performances and clinical added value of the MultiSense® ambulatory telemonitoring solution in real-life situations.
Detailed Description
The MultiSense® solution is a medical device for telemonitoring for in and outpatient use. It includes 5 physiological data sensors and communicates via Bluetooth with a smartphone. The data is centr...
Eligibility Criteria
Inclusion
- Adult (male or female over 18 years) in non-critical care settings
- Patient programmed for an elective surgery
- Need to monitor at home at least one physiological parameter: heart rate, respiratory rate, SpO2, temperature, physical activity
- Patient able to use a smartphone
- Patient with Wi-Fi and/or Cellular connectivity at home
- Patient with a personal phone which allows to receive text messages
- Patient able to receive and understand information related to the study and give written informed consent
- Patient affiliated to the French social security system
Exclusion
- Patient with known skin allergy (adhesive or silicon) or skin disease that would not allow the use of an adhesive
- Patient with an active implantable device (such as a pacemaker or automatic defibrillator)
- Patient with an elective imagery planned during the use of MultiSense
- Pregnant or lactating patient
- Patient in exclusion period (determined by a previous or a current study)
- Patient under guardianship or trusteeship
- Patient under the protection of justice or deprived of liberty
- Patient in situation of emergency
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05357729
Start Date
June 14 2022
End Date
September 2 2022
Last Update
January 5 2024
Active Locations (1)
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1
Service de Chirurgie Digestive et Endocrinienne
Strasbourg, France, 67000