Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
NCT ID: NCT06647017
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-11-01
2025-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active tAN + standard of care
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.
Volta tAN System
Transcutaneous auricular neurostimulation (tAN)
Sham tAN + standard of care
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.
SHAM Volta tAN System
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.
Interventions
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Volta tAN System
Transcutaneous auricular neurostimulation (tAN)
SHAM Volta tAN System
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is between 18 and 75 years of age
* Participant is English proficient
* Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
Exclusion Criteria
* Participant is currently taking a platelet inhibitor medication
* Participant has a history of epileptic seizures
* Participant has a history of neurological diseases or traumatic brain injury
* Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
* Participant has abnormal ear anatomy or ear infection present
* Person of childbearing age, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
* Person who is pregnant or lactating
* Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
18 Years
75 Years
ALL
No
Sponsors
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Spark Biomedical, Inc.
INDUSTRY
University Surgical Vascular
INDUSTRY
Responsible Party
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Locations
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University Surgical Vascular
Watkinsville, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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David Sailors, MD
Role: primary
Other Identifiers
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1983231
Identifier Type: -
Identifier Source: org_study_id
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