Informed Consent for Participation in an Investigational Medical Device Clinical Trial

Section 1info grid
Section 2text block
Section 3text block
Section 4list block
Section 5list block
Section 6list block
Section 7text block
Section 8text block
Section 9text block
Section 10text block
Section 11text block
Section 12text block
Section 13text block
Section 14text block
Section 15text block
Section 16signature block

Informed Consent for Participation in an Investigational Medical Device Clinical Trial

Participant and Trial Information

1. Purpose and Nature of the Device Trial

This clinical trial is designed to evaluate the safety and effectiveness of an investigational medical device. An investigational device is one that has not yet been cleared or approved by the FDA for general sale. The trial seeks to determine if the device is safe to use and if it provides clinical benefit compared to current treatments. By signing this form, you agree to participate in this study. The device will be applied, activated, or surgically implanted in your body under the supervision of the principal investigator. You will be monitored closely throughout the trial.

2. Device Implantation or Application Steps

The study device will be introduced into your care plan: (1) Implantation/Application: [Describe surgical or non-surgical placement]. (2) Programming and Calibration: The device will be configured to your clinical needs during an initial clinic visit. (3) Daily Use: You will use or wear the device according to the trial instructions. (4) Data Collection: The device may transmit physiological data to the study portal automatically or store it internally for download.

3. Short-Term Insertion and Surgical Risks

Surgical placement risks: local bleeding, pain, swelling, or hematoma formation at the insertion site.
Local infection: bacteria entering the insertion wound, which may require antibiotics or surgical removal of the device.
Sedation or anesthesia risks: minor breathing changes, nausea, or drug reactions during the placement procedure.

4. Long-Term and Hardware Risks

Device malfunction or failure: the device battery may fail early, the software may glitch, or the physical hardware may break or wear down, requiring a surgical procedure to replace or remove the device.
Tissue irritation or erosion: the device may rub or erode through surrounding tissues, causing chronic pain, scarring, or localized tissue damage.
Device migration: the implanted device may shift from its original placement site, requiring surgical repositioning.
Allergic reaction: localized skin or tissue reaction to the metals, plastics, or adhesives used in the device.

5. Alternatives to Device Trial Participation

Using currently FDA-approved devices or treatments that are already commercially available for your condition.
Medication-based therapy plans or surgical alternatives without the use of an investigational device.
Choosing not to participate, and continuing with your current medical care plan.

6. Device Retrieval and Return Mandates

Because the device is investigational and remains the property of the study sponsor, you are required to return the device: (1) At the end of the trial period, (2) If the study is terminated early by the sponsor, FDA, or IRB, (3) If you choose to withdraw from the trial. If the device was surgically implanted, the sponsor will cover the cost of the surgical removal procedure. You must return all external components, chargers, and recording units to the clinic within 14 days of study completion or withdrawal.

7. Safety Monitoring and Follow-Up Schedule

Participating in this trial requires your commitment to a strict follow-up schedule: (1) You must attend all scheduled clinic visits for device checks, calibration, and safety assessments. (2) You must complete all diaries or questionnaires detailing device use and side effects. (3) You must participate in all required follow-up imaging (X-rays, CTs) or laboratory tests.

8. Injury and Cost Disclosures

The study sponsor will provide the investigational device and all study-related visits and tests at no cost to you. If you suffer a physical injury directly caused by the study device or the placement procedure: the sponsor will cover the cost of necessary medical treatment for the injury, provided you follow the study protocol. No other compensation (such as lost wages or pain and suffering) is offered.

9. Right to Withdraw from the Trial

You have the right to withdraw from the trial at any time. If you withdraw: **you must return the study device**. If the device is implanted, you must schedule a surgical removal procedure for your safety. Stopping the trial without removing the device may carry serious health risks, which your physician will discuss with you.

10. Institutional Review Board (IRB) Oversight

This clinical trial has been reviewed and approved by an Institutional Review Board (IRB) to protect participant safety. If you have questions about your rights as a participant, you can contact the IRB office at [IRB contact info].

11. Participant Understanding and Questions

I confirm that I have read this document and understand the medical device trial, the placement procedure, the hardware and software risks, the device return mandate, and the safety monitoring schedule. All my questions have been answered.

12. Language Access Services

If English is not your primary language, a qualified interpreter is available at no cost. Please inform staff before signing.

13. Copy of Consent Acknowledgment

I acknowledge that I have been offered a copy of this signed consent form.

14. Participant Authorization

I voluntarily consent to participate in the medical device trial. I authorize the device implantation/application, calibration, and safety monitoring. I agree to follow the follow-up schedule and to return the device if I withdraw or when the study ends.

Signatures and Verification

Participant Signature
Parent / Guardian Signature (if participant is a minor)
Witness Signature
Date and Time of Consent
Document ID: CC-PENDING
CONSENTCOLLECT