Assessing the Safety and Efficacy of a Novel Subcutaneous Implant Insertion Device on Healthy Adults

Stopped early · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

The investigators have created a device designed to make it easier to insert pharmaceutical implants under the skin. The device uses a blood pressure cuff to hold the skin on a person's arm in place while a mechanical guide places implants underneath the skin. This device may prevent implants from being embedded too deeply. The investigators are performing this study to determine the safety and efficacy of the device for use in adult women. The study will determine if the implants are placed accurately under the skin (in the sub-dermal layer). It will also assess if the device causes any discomfort or last pain from use.

Key facts

Study ID

NCT03621787

Run by

University of Michigan

People needed

9

Starts

2018-11-08

Expected to finish

2019-12-01

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult subjects aged 18 to 49
• Ability to understand study procedure and informed consent document

You may not qualify if…

• Patients with a history of keloid scarring
• Pregnancy
• Any rashes or skin conditions around the insertion site
• Known silicone allergies
• Known allergy to lidocaine
• History of bleeding disorders or abnormal bleeding

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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