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

Not Applicable

Terminated

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Single arm study: implant insertion	Implant insertion device	Participants in trial will be within a single study arm. All participants will have a placebo subcutaneous implant inserted with the device being studied. The implant accuracy will be assess through palpation and ultrasound depth measurements. The implant will then be removed. Safety will be assessed by measuring bruising and bleeding. A follow-up questionnaire will assess bruising and infection risk. A final visit will assess bruising and infection risk by a physician.

Primary Outcome Measures

Name	Time	Method
Implant Depth: Distal End	Up to 60 minutes after insertion	Depth of distal end of implant beneath the skin after insertion. Measured via high frequency ultrasound with linear probe. Measured in centimeters below skin surface. Measurements will be aggregated via mean and standard deviation.
Implant Depth: Proximal End	Up to 60 minutes after insertion	Depth of distal end of implant beneath the skin after insertion. Measured via high frequency ultrasound with linear probe. Measured in centimeters below skin surface. Measurements will be aggregated via mean and standard deviation.
Implant Palpability	Up to 15 minutes after insertion	A binary (yes/no) assessment of whether the implant is palpable by a physician under the skin after insertion. Measurements will be aggregated based on percent of implants that are palpable.

Secondary Outcome Measures

Name	Time	Method
Presence of Bruising	7 to 14 days after insertion	Bruising may occur from inflation of the blood pressure cuff over the device being studied. Bruising will be assessed by the participant in a survey (binary yes/no indication of bruising around insertion site).
Number of Participants With Bruising	Up to 15 minutes after insertion.	Bruising may occur from inflation of the blood pressure cuff over the device being studied. A binary assessment of bruising (yes/no) will be assessed by the physician after insertion.
Number of Participants With More Bleeding Than Typical	Up to 10 minutes after insertion	Bleeding from insertion will be assessed by the physician who has extensive training with implant insertions. The number of participants with more bleeding than is typically associated with insertion will be measured.
Number of Participants With Signs of Infection	21 to 28 days after insertion	A follow-up appointment with all participants was conducted by the physician who administered the implant. A binary assessment (yes/no) of the following will be assessed for each participant by the physician. 1) Is there currently any fluid draining from the incision? 2) Is there currently any redness or swelling of the insertion site? 3) Is there currently any bleeding from the insertion site? If the physician answers "Yes" to all three questions, the participant is deemed to have shown signs of infection.