Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the postoperative period allows for a reduction in pain intensity in terms of Numerical Rating Scale (NRS) score and use of analgesic drugs.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Breast cancer patients undergoing unilateral mastectomy with reconstruction and without axillary dissection
Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Daniele Sances, MD
daniele.sances@ieo.it
+390257489618
Time Frame
Start Date: 2023-05-09
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 160
Treatments
Experimental: Active AlgoCare
An active AlgoCare device (that emits a pulsed radio frequency electromagnetic field at 27.1 MHz) will be placed over the surgical dressing using a plaster or bandage for six days.
Placebo_comparator: Non-active AlgoCare
A non-active AlgoCare device (that doesn't emit pulsed radio frequency electromagnetic field) will be placed over the surgical dressing using a plaster or bandage for six days.
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology