NCT06331793|Unknown
Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
Algocare
Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
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Algocare
Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
Sponsor study identifier
interventional
160
1 country
1
Study Start
May 9, 2023
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 9, 2023
Actual (reported)March 18, 2024
Actual (reported)March 26, 2024
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pain intensity
Difference in mean NRS score between the two arms, at 24 hours and 72 hours after surgery (minimum value: 0, maximum value: 10 - higher scores mean a worse outcome)
72 hours
Need for analgesic drugs
3 months
Patient reported pain characteristics
3 months
Number of participants with other symptoms
3 months
Need for other drugs
3 months
Wound healing timing
3 months
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.
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.
Device that emits Pulsed Electromagnetic Fields
Device that doesn't emit Pulsed Electromagnetic Fields
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
European Institute of Oncology
Milan, 20141, Italy
Daniele Sances, MD
European Institute of Oncology
First Submitted
March 18, 2024
First Posted
March 26, 2024
Study Start
May 9, 2023
Actual (reported)Primary Completion
December 31, 2024
Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 26, 2024
Record last verified: 2024-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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