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| Name | Class |
|---|---|
| Spark Biomedical, Inc. | INDUSTRY |
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The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
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 1:1 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tAN + standard of care | Experimental | Participants randomized to the active group will have an earpiece applied and receive 30 minutes of active tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed. |
|
| Sham tAN + standard of care | Sham Comparator | Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on. These participants will receive 30 minutes of sham tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volta tAN System | Device | Transcutaneous auricular neurostimulation (tAN) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Total Blood Loss | Comparison of mean total quantified blood loss in active tAN versus sham tAN groups. | Throughout procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery Time | Surgery time measured as total time from first incision to incision closure in active tAN versus sham tAN groups. | First incision to incision closure |
| Time to Hemostasis | Comparison of mean time to hemostasis in active tAN versus sham tAN groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic Agent Use | Proportion of participants requiring hemostatic agents | During surgery |
| Duration of time between completing graft placement and application/administration of hemostatic agent | Duration of time between completing graft placement and application/administration of hemostatic agent |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Sailors, MD | Contact | (706) 549-8306 | dsailors@gasurgery.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Surgical Vascular | Recruiting | Watkinsville | Georgia | 30677 | United States |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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The participants and investigator will be blind to participant treatment group assignment. Only the research coordinator will know treatment group assignment.
| SHAM Volta tAN System | Device | Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on. |
|
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| From end of AV graft placement to beginning of surgical site closure |
| During surgery |
| Proportion of participants achieving hemostasis in <10 minutes | Proportion of participants achieving hemostasis in <10 minutes | During surgery |
| Blood Assay Results | Blood urea nitrogen (BUN) levels, platelet count, hematocrit, and activated clotting time (ACT) | Prior to device placement, during surgery, and at end of surgery |
| Treatment-Related Adverse Events (Safety) | The proportion of participants who experience one or more treatment-related adverse events. | Thorough study completion, an average of 4 hours |