Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533917
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Spinal Cord Stimulation for Chronic Abdominal Pain Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Spinal Cord Stimulation for Chronic Abdominal Pain Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic abdominal pain is a common disorder that can have significant impact on the lives of patients Treatment options include medication which can have limited effectiveness be associated with side effects and may lead to tolerance and dependency Spinal cord stimulation SCS is a minimally invasive therapeutic option for managing chronic abdominal pain This involves implanting a device that delivers mild electrical signals to the spinal cord to reduce pain Conventional SCS has been shown to improve abdominal pain caused by different disorders but it causes feelings of unpleasant tingling in the tummy area This feasibility study aims to explore relief from chronic abdominal pain symptoms when using a device that does not cause uncomfortable tingling feelings in the tummy area
Detailed Description:
Up to 20 patients with chronic abdominal pain will be recruited to participate in this study They will attend an initial visit prior to having the device implanted and they will be asked to complete a number of questionnaires Participants will then attend the hospital to have the device implanted and the treatment settings of the stimulation adjusted Once the stimulation is started participants will be continuously monitored for their well-being through a series of in-person visits at the pain clinic on a regular basis These will happen at 1 week and 3 6 and 12 months after having the device implanted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None