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

Subcutaneous contraceptive implants are one of the preferred methods of long-term
contraception by the World health Organization and ministries of health in low- and
middle-income countries. These implants offer between three and five years of protection
(allowing women to safely space pregnancies and thereby reduce maternal and infant
mortality), are 99.95% efficacious, allow women to return to fertility quickly when removed,
requires no daily/monthly effort on the part of the woman, and cause minimal side effects in
comparison to other methods. However, availability of contraceptive implants in rural areas
is limited due to the skill necessary to administer them safely and accurately.

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 is
designed to prevent implants from being embedded too deeply.

In this trial, the investigators will use the implant insertion device with a placebo
sub-cutaneous implant. Implants will be inserted with the device and the accuracy of the
placement will be assessed through palpation and ultrasound depth measurements. This data
will allow the investigators to assess whether the device ensures accurate insertions of
sub-cutaneous implants.

Inclusion Criteria:

- Healthy adult subjects aged 18 to 49

- Ability to understand study procedure and informed consent document

Exclusion Criteria:

- 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