Clinical trial NCT03621787: Assessing the Safety and Efficacy of a Novel Subcutaneous Implant Insertion Device on Healthy Adults
Official title: Assessing the Safety and Efficacy of the SubQ Assist Implant Insertion Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Translation and Commercialization for Life Sciences Hub
name: Grand Challenges Canada
name: VentureWell
name: Unite for Sight
First posted: 2018-08-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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, bleeding, and pain to participant. A follow-up questionnaire will assess pain, bruising, and infection risk. A final visit will assess pain, bruising, and infection risk by a physician.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant Depth: Distal End
timeFrame: Up to 60 minutes after insertion
measure: Implant Depth: Proximal End
timeFrame: Up to 60 minutes after insertion
measure: Implant Palpability
timeFrame: Up to 15 minutes after insertion
Secondary outcomes:
measure: Number of Participants With Bruising
timeFrame: Up to 15 minutes after insertion.
measure: Presence of Bruising
timeFrame: 7 to 14 days after insertion
measure: Number of Participants With More Bleeding Than Typical
timeFrame: Up to 10 minutes after insertion
measure: Number of Participants With Signs of Infection
timeFrame: 7 to 10 days after insertion
measure: Number of Participants With Signs of Infection
timeFrame: 21 to 28 days after insertion
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Associate Professor
name: Kathleen H Sienko, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Carrie L Bell, MD
role: PRINCIPAL_INVESTIGATOR
References: