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Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer

NCT03889288 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-03-02

No results posted yet for this study

Summary

The objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. This new modality of pain management is evaluated in a perioperative management in patients undergoing surgery for aortic valve replacement.

The hypothesis is that the use of this medical device in perioperative would reduce the consumption of postoperative morphine with an identical quality of analgesia. The decline in morphine consumption would allow a decrease in opioid adverse effects.

Conditions

  • Aortic Valve Replacement

Interventions

DEVICE

Medical device - electronic-pain killer

Treatment sessions with the medical device (no-marked EC): 2 sessions before surgery and 4 or 5 sessions until 48 hours after surgery. Each treatment sessions takes 45 minutes. Each session is spaced by 12 +/-3 hours.

Sponsors & Collaborators

  • Remedee SA

    collaborator INDUSTRY

  • Clinical Investigation Centre for Innovative Technology Network

    collaborator NETWORK

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Pierre Albaladejo, MD, PhD · Grenoble Alpes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-16
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03889288 on ClinicalTrials.gov