Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331793
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-18
Brief Title:
Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Algocare
Brief 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
Detailed Description:
The treatment of postoperative pain is a priority issue for both the doctor and the patient Obtaining adequate analgesia in the first postoperative days in fact is essential for the patients comfort but also to promote and accelerate functional recovery and prevent chronic pain which in the case of breast surgery has a high incidence 20-60
The use of pulsed electromagnetic fields PEMF for the treatment of pain and inflammation has been widely studied and validated
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 This is a field of application in which this technique analgesic has never been tested but in which it could prove valid within a multimodal analgesia protocol as the pain caused by this type of intervention is predominantly parietal and resulting from tissue trauma caused by the surgical wound AlgoCare is a non-invasive and non-pharmacological device developed specifically for treatment of post-operative inflammation and pain CE certified and registered with the Ministry of Health It emits a pulsed radio frequency electromagnetic field at 271 MHz a frequency already studied and approved for medical use
The use of pulsed electromagnetic fields PEMF for the treatment of pain and inflammation has been widely studied and validated
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 This is a field of application in which this technique analgesic has never been tested but in which it could prove valid within a multimodal analgesia protocol as the pain caused by this type of intervention is predominantly parietal and resulting from tissue trauma caused by the surgical wound AlgoCare is a non-invasive and non-pharmacological device developed specifically for treatment of post-operative inflammation and pain CE certified and registered with the Ministry of Health It emits a pulsed radio frequency electromagnetic field at 271 MHz a frequency already studied and approved for medical use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None