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

Healthy Clinical Trial

Official title:

Assessing the Safety and Efficacy of the SubQ Assist Implant Insertion Device

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03621787
• Other study ID #: SubQAssist0001
• Status: Terminated
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: October 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Implant insertion device
Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan	Grand Challenges Canada, Michigan Translation and Commercialization for Life Sciences Hub, Unite for Sight, VentureWell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Depth: Distal End	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.	Up to 60 minutes after insertion
Primary	Implant Depth: Proximal End	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.	Up to 60 minutes after insertion
Primary	Implant Palpability	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.	Up to 15 minutes after insertion
Secondary	Number of Participants With Bruising	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.	Up to 15 minutes after insertion.
Secondary	Presence of Bruising	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).	7 to 14 days after insertion
Secondary	Number of Participants With More Bleeding Than Typical	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.	Up to 10 minutes after insertion
Secondary	Number of Participants With Signs of Infection	Infection will be assessed during the follow-up questionnaire. A binary assessment (yes/no) of the following will be assessed by the participant. 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?; Participants who answer "Yes" to all three questions are deemed to have shown signs of infection.	7 to 10 days after insertion
Secondary	Number of Participants With Signs of Infection	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.	21 to 28 days after insertion