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

NCT03621787 | Terminated Results FDA Device

• 1 other identifier: SubQAssist0001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Number of Participants With Bruising

  Up to 15 minutes after insertion.

• Presence of Bruising

  7 to 14 days after insertion

• Number of Participants With More Bleeding Than Typical

  Up to 10 minutes after insertion

• Number of Participants With Signs of Infection

  7 to 10 days after insertion

• Number of Participants With Signs of Infection

  21 to 28 days after insertion

Study Arms (1)

Single arm study: implant insertion

EXPERIMENTAL

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.

Device: Implant insertion device

Interventions

Implant insertion device DEVICE

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

Also known as: SubQ Assist

Single arm study: implant insertion

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult subjects aged 18 to 49
• Ability to understand study procedure and informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Michigan Translation and Commercialization for Life Sciences Hub: collaborator
• Grand Challenges Canada: collaborator
• VentureWell: collaborator
• Unite for Sight: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Kathleen Sienko
• Organization: co-PI

sienko@umich.edu

734647249

Study Officials

• Kathleen H Sienko, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

• Carrie L Bell, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: November 8, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Locations

US (1)