Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Volta tAN System, SHAM Volta tAN System.
- Who it may be relevant to
- Registry conditions: Blood Loss, Surgical. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Interventions
- Device Volta tAN System
Transcutaneous auricular neurostimulation (tAN) - Device SHAM Volta tAN System
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.
Primary outcome measures
- Mean Total Blood Loss [Time frame: Throughout procedure]
Secondary outcome measures (2)
- Surgery Time [Time frame: First incision to incision closure]
- Time to Hemostasis [Time frame: From end of AV graft placement to beginning of surgical site closure]
Eligibility criteria
Inclusion criteria
- Participant is undergoing a dialysis port placement procedure using synthetic graft
- 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 has a BMI ≥ 40
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Surgical Vascular — Watkinsville
Identifiers
NCT: NCT06647017 · 1983231