Neurostimulation Therapy for Reducing Blood Loss

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Surgical Vascular

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.

Eligibility Criteria

This trial is for individuals undergoing dialysis AV graft placement procedures. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study or increase risk.

Inclusion Criteria

I can understand and agree to the study's requirements.

Participant is English proficient

I am getting a dialysis port with a synthetic graft.

Exclusion Criteria

My BMI is 40 or higher.

I am currently on medication to prevent blood clots.

I have an ear infection or my ear shape is unusual.

Participant Groups

The study is testing whether tAN therapy using the Volta tAN System can reduce blood loss during AV graft placement compared to a SHAM (placebo-like) device. Participants will be randomly assigned to receive either the actual tAN therapy or a non-functional sham treatment.

Group I: Active tAN + standard of care Experimental Treatment 1 Intervention

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.

Group II: Sham tAN + standard of care Placebo Group 1 Intervention

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.

Transcutaneous Auricular Neurostimulation is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Transcutaneous Auricular Neurostimulation for:

• Chronic pain
• Opioid withdrawal
• Irritable bowel syndrome

🇪🇺 Approved in European Union as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Chronic pain
• Temporomandibular disorders

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University Surgical Vascular Watkinsville, GA

Who Is Running the Clinical Trial?

University Surgical Vascular Lead Sponsor

Spark Biomedical, Inc. Industry Sponsor

References