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

NCT03621787 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-11-19

Study results available
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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

Interventions

DEVICE

Implant insertion device

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

Sponsors & Collaborators

  • Michigan Translation and Commercialization for Life Sciences Hub

    collaborator OTHER

  • Grand Challenges Canada

    collaborator OTHER

  • VentureWell

    collaborator INDUSTRY

  • Unite for Sight

    collaborator OTHER

  • University of Michigan

    lead OTHER

Principal Investigators

  • Kathleen H Sienko, PhD · Associate Professor

  • Carrie L Bell, MD · Assistant Professor

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2019-11-01
Completion
2019-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621787 on ClinicalTrials.gov