Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03621787
Recruitment Status : Terminated (Expiration of study funds.)
First Posted : August 8, 2018
Results First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborators:
Michigan Translation and Commercialization for Life Sciences Hub
Grand Challenges Canada
VentureWell
Unite for Sight
Information provided by (Responsible Party):
Ibrahim Mohedas, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Healthy Device: Implant insertion device Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessing the Safety and Efficacy of the SubQ Assist Implant Insertion Device
Actual Study Start Date : November 8, 2018
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: 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.
Device: Implant insertion device
Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Other Name: SubQ Assist




Primary Outcome Measures :
  1. Implant Depth: Distal End [ Time Frame: Up to 60 minutes after insertion ]
    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.

  2. Implant Depth: Proximal End [ Time Frame: Up to 60 minutes after insertion ]
    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.

  3. Implant Palpability [ Time Frame: Up to 15 minutes after insertion ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Bruising [ Time Frame: Up to 15 minutes after insertion. ]
    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.

  2. Presence of Bruising [ Time Frame: 7 to 14 days after insertion ]
    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).

  3. Number of Participants With More Bleeding Than Typical [ Time Frame: Up to 10 minutes after insertion ]
    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.

  4. Number of Participants With Signs of Infection [ Time Frame: 7 to 10 days after insertion ]

    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.


  5. Number of Participants With Signs of Infection [ Time Frame: 21 to 28 days after insertion ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621787


Locations
Layout table for location information
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Michigan Translation and Commercialization for Life Sciences Hub
Grand Challenges Canada
VentureWell
Unite for Sight
Investigators
Layout table for investigator information
Principal Investigator: Kathleen H Sienko, PhD Associate Professor
Principal Investigator: Carrie L Bell, MD Assistant Professor
  Study Documents (Full-Text)

Documents provided by Ibrahim Mohedas, University of Michigan:
Study Protocol  [PDF] November 17, 2018
No Statistical Analysis Plan (SAP) exists for this study.

Layout table for additonal information
Responsible Party: Ibrahim Mohedas, Postdoctoral Fellow, University of Michigan
ClinicalTrials.gov Identifier: NCT03621787    
Other Study ID Numbers: SubQAssist0001
First Posted: August 8, 2018    Key Record Dates
Results First Posted: November 19, 2020
Last Update Posted: November 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No