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

NCT06647017 | Not Yet Recruiting FDA Device

• 1 other identifier: 1983231
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss, Surgical

Keywords

auricular neurostimulation; vagus nerve stimulation; transcutaneous; blood loss; transcutaneous auricular neurostimulation; tAN

Outcome Measures

Primary Outcomes (1)

• Mean Total Blood Loss

  Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.

  Throughout procedure

Secondary Outcomes (2)

• Surgery Time

  First incision to incision closure

• Time to Hemostasis

  From end of AV graft placement to beginning of surgical site closure

Other Outcomes (5)

• Hemostatic Agent Use

  During surgery

• Duration of time between completing graft placement and application/administration of hemostatic agent

  During surgery

• Proportion of participants achieving hemostasis in <10 minutes

  During surgery

Study Arms (2)

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.

Device: Volta tAN System

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.

Device: SHAM Volta tAN System

Interventions

Volta tAN System DEVICE

Transcutaneous auricular neurostimulation (tAN)

Also known as: Sparrow Ascent

Active tAN + standard of care

SHAM Volta tAN System DEVICE

Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.

Also known as: Sparrow Ascent

Sham tAN + standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Surgical Vascular: lead
• Spark Biomedical, Inc.: collaborator

Study Sites (1)

University Surgical Vascular

Watkinsville, Georgia, 30677, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Central Study Contacts

David Sailors, MD

CONTACT

(706) 549-8306; dsailors@gasurgery.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants and investigator will be blind to participant treatment group assignment. Only the research coordinator will know treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 17, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 31, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-10

Locations

US (1)