Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 6:14 AM
Study NCT ID:
NCT04818294
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Monitor the Efficacy of the Elosan Treatment by Applying Electrostatic
Sponsor:
Elosan AG
Organization:
Study Overview
Official Title:
Prospective, Multi-center, Clinical Trial (Phase IV Study) to Monitor the Efficacy of Treatment by Applying a High Electrostatic Charge to Patients With Chronic Pain, in the Practice of Clinical or Out-patient Pain Treatment Facilities.
Status:
COMPLETED
Status Verified Date:
2023-01
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:
None
Brief Summary:
The Treatment Cabin 'Elosan cabin' is a closed, electrically insulated cabin for the short-term application of a high electrostatic voltage to the body of patients with chronic pain.
Patients assigned will have 8 sessions in the treatment cabin, with an interval of 6 days between sessions. The existing therapies and painkillers will be continued at the discretion of the doctor.
Patients assigned will have 8 sessions in the treatment cabin, with an interval of 6 days between sessions. The existing therapies and painkillers will be continued at the discretion of the doctor.
Detailed Description:
Included in the study can be all persons suffering from chronic pain as it is often the case with rheumatic disease or traumata. The electric charge is created by a generator which can produce a high electrostatic field. The electrical voltage is delivered to the hands via a metal handle and is spread over the entire body surface. After the short treatment, the patient is completely discharged and earthed again.
Over 100 patients in eight pain centers are to be included into this trial in order to show a statistically significant reduction of pain.
Over 100 patients in eight pain centers are to be included into this trial in order to show a statistically significant reduction of pain.
Study Oversight
Has Oversight DMC:
False
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?: