Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures

University Surgical Vascular

Status: Not yet enrolling

Conditions: Blood Loss, Surgical

Treatments: Device: Volta tAN System; Device: SHAM Volta tAN System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06647017

1983231

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Active tAN + standard of care

Experimental group

Description:

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.

Treatment:

Device: Volta tAN System

Sham tAN + standard of care

Sham Comparator group

Description:

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.

Treatment:

Device: SHAM Volta tAN System