Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647017
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures
Detailed Description:
This study is designed as a randomized double-blind sham-controlled single-center pilot clinical trial in which adults undergoing dialysis port placement procedures will be randomized 11 into one of two treatment groups
Group 1 Active tAN standard of care Group 2 Sham tAN standard of care
Participants will receive 30 minutes of active or sham tAN immediately prior to the dialysis port placement procedure Blood loss and blood markers will be measured before and during the procedure to measure the effect of the therapy
Group 1 Active tAN standard of care Group 2 Sham tAN standard of care
Participants will receive 30 minutes of active or sham tAN immediately prior to the dialysis port placement procedure Blood loss and blood markers will be measured before and during the procedure to measure the effect of the therapy
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