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

NCT ID: NCT03621787

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-08
• Study Completion Date: 2019-12-01

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single arm study: implant insertion

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.

Group Type: EXPERIMENTAL

Implant insertion device

Intervention Type: DEVICE

Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.

Interventions

Implant insertion device

Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.

Intervention Type: DEVICE

Other Intervention Names

SubQ Assist

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan Translation and Commercialization for Life Sciences Hub

OTHER

Sponsor Role: collaborator

Grand Challenges Canada

OTHER

Sponsor Role: collaborator

VentureWell

INDUSTRY

Sponsor Role: collaborator

Unite for Sight

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Mohedas

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen H Sienko, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Carrie L Bell, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

SubQAssist0001

Identifier Type: -

Identifier Source: org_study_id