Status:

TERMINATED

Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena.

Lead Sponsor:

University of Toledo Health Science Campus

Collaborating Sponsors:

ElectroCore INC

Conditions:

Raynaud Phenomenon

Primary Raynaud Phenomenon

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Raynaud's phenomenon (RP) is a common vascular disorder that affects approximately 10% of the general population. RP is associated with significant morbidity that may include loss of the digits due to...

Detailed Description

Raynaud's phenomenon (RP) is a common vascular disorder that that affects approximately 10% of the general population. RP causes some areas of the body (i.e. fingers and toes) to feel cold and numb in...

Eligibility Criteria

Inclusion

  • • Clinical Diagnosis of Primary Raynaud's Phenomenon

Exclusion

  • Less than 18 years of age
  • Pregnant women
  • Current smokers
  • Have Digital ulcers
  • Diagnosed Pulmonary hypertension
  • Currently on vasodilators (i.e. Phosphodiesterase type 5 inhibitors, prostacyclin, nitroglycerine, or other nitric oxide derivatives)
  • Currently on Calcium Channel Blockers

Key Trial Info

Start Date :

April 30 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 27 2020

Estimated Enrollment :

6 Patients enrolled

Trial Details

Trial ID

NCT03869008

Start Date

April 30 2019

End Date

February 27 2020

Last Update

July 15 2025

Active Locations (1)

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Unversity of Toledo Medical Center

Toledo, Ohio, United States, 43614