NCT03889288

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

Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-06-16
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2019-03-26
• Last updated: 2021-03-02

Locations

1 site across 1 country: France