Informed Consent Form for Medical Device Trial

Trial Title:

Introduction

Purpose of the Trial

Procedures

Potential Risks and Discomforts

Potential Benefits

Confidentiality

Voluntary Participation and Withdrawal

Questions / Contact Information

Statement of Consent

I have read and understood the information above.
I have had the opportunity to ask questions and received satisfactory answers.
I voluntarily agree to participate in this medical device trial.

Participant Name Date

Participant Signature

Investigator Name Date

Investigator Signature