Trial Outcomes & Findings for Assessing the Safety and Efficacy of a Novel Subcutaneous Implant Insertion Device on Healthy Adults (NCT NCT03621787)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Up to 60 minutes after insertion

Results posted on

2020-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Study: Implant Insertion n=9 Participants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Sex: Female, Male Female	7 Participants n=9 Participants
Sex: Female, Male Male	2 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants
Arm circumference	23.67 centimeters STANDARD_DEVIATION 1.95 • n=9 Participants
Weight	62.57 kilograms STANDARD_DEVIATION 11.86 • n=9 Participants
Height	167.5 centimeters STANDARD_DEVIATION 10.9 • n=9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study: Implant Insertion n=18 Implants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Implant Depth: Distal End	0.26 centimeters Standard Deviation 0.05

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study: Implant Insertion n=18 implants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Implant Depth: Proximal End	.35 centimeters Standard Deviation .07

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study: Implant Insertion n=18 implants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Implant Palpability	18 palpable implants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study: Implant Insertion n=9 Participants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Number of Participants With Bruising	1 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Single Arm Study: Implant Insertion n=9 Participants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Presence of Bruising	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study: Implant Insertion n=9 Participants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Number of Participants With More Bleeding Than Typical	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study: Implant Insertion n=9 Participants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Number of Participants With Signs of Infection	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study: Implant Insertion n=9 Participants 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Number of Participants With Signs of Infection	0 Participants

Adverse Events

Single Arm Study: Implant Insertion

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm Study: Implant Insertion n=9 participants at risk 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. Implant insertion device: Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Surgical and medical procedures Difficulty removing implant	11.1% 1/9 • Number of events 1 • Adverse events were tracked for each participant from the beginning of the study through their follow-up appointment. Up to 28 days.

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Sienko

co-PI

Phone: 734647249

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place