Assessing the Safety and Efficacy of a Novel Subcutaneous Implant Insertion Device on Healthy Adults
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Implant Depth: Distal End [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.
- Implant Depth: Proximal End [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.
- Implant Palpability [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
- Number of Participants With Bruising [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.
- Presence of Bruising [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).
- Number of Participants With More Bleeding Than Typical [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.
- Number of Participants With Signs of Infection [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.
- Number of Participants With Signs of Infection [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Principal Investigator: Kathleen H Sienko, PhD, Associate Professor
- Principal Investigator: Carrie L Bell, MD, Assistant Professor
Study Documents (Full-Text)
More Information
Publications
None provided.- SubQAssist0001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Period Title: Overall Study | |
| STARTED | 9 |
| COMPLETED | 9 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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 Participants | 9 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
9
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
77.8%
|
| Male |
2
22.2%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
9
100%
|
| Arm circumference (centimeters) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [centimeters] |
23.67
(1.95)
|
| Weight (kilograms) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kilograms] |
62.57
(11.86)
|
| Height (centimeters) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [centimeters] |
167.5
(10.9)
|
Outcome Measures
| Title | Implant Depth: Distal End |
|---|---|
| Description | 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. |
| Time Frame | Up to 60 minutes after insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 9 |
| Measure Implants | 18 |
| Mean (Standard Deviation) [centimeters] |
0.26
(0.05)
|
| Title | Implant Depth: Proximal End |
|---|---|
| Description | 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. |
| Time Frame | Up to 60 minutes after insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 9 |
| Measure implants | 18 |
| Mean (Standard Deviation) [centimeters] |
.35
(.07)
|
| Title | Implant Palpability |
|---|---|
| Description | 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. |
| Time Frame | Up to 15 minutes after insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 9 |
| Measure implants | 18 |
| Number [palpable implants] |
18
|
| Title | Number of Participants With Bruising |
|---|---|
| Description | 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. |
| Time Frame | Up to 15 minutes after insertion. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 9 |
| Count of Participants [Participants] |
1
11.1%
|
| Title | Presence of Bruising |
|---|---|
| Description | 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). |
| Time Frame | 7 to 14 days after insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 9 |
| Count of Participants [Participants] |
1
11.1%
|
| Title | Number of Participants With More Bleeding Than Typical |
|---|---|
| Description | 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. |
| Time Frame | Up to 10 minutes after insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 9 |
| Count of Participants [Participants] |
1
11.1%
|
| Title | Number of Participants With Signs of Infection |
|---|---|
| Description | 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. |
| Time Frame | 7 to 10 days after insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 9 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Signs of Infection |
|---|---|
| Description | 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. |
| Time Frame | 21 to 28 days after insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study: Implant Insertion |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 9 |
| Count of Participants [Participants] |
0
0%
|
Adverse Events
| Time Frame | Adverse events were tracked for each participant from the beginning of the study through their follow-up appointment. Up to 28 days. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Single Arm Study: Implant Insertion | |
| Arm/Group 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 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. | |
All Cause Mortality |
||
| Single Arm Study: Implant Insertion | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | |
Serious Adverse Events |
||
| Single Arm Study: Implant Insertion | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/9 (11.1%) | |
| Surgical and medical procedures | ||
| Difficulty removing implant | 1/9 (11.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Single Arm Study: Implant Insertion | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kathleen Sienko |
|---|---|
| Organization | co-PI |
| Phone | 734647249 |
| sienko@umich.edu |
- SubQAssist0001