Assessing the Safety and Efficacy of a Novel Subcutaneous Implant Insertion Device on Healthy Adults
Assessing the Safety and Efficacy of the SubQ Assist Implant Insertion Device
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Implant Depth: Distal End
時間枠：Up to 60 minutes after insertion
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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.
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Up to 60 minutes after insertion
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Implant Depth: Proximal End
時間枠：Up to 60 minutes after insertion
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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.
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Up to 60 minutes after insertion
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Implant Palpability
時間枠：Up to 15 minutes after insertion
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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.
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Up to 15 minutes after insertion
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Bruising
時間枠：Up to 15 minutes after insertion.
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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.
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Up to 15 minutes after insertion.
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Presence of Bruising
時間枠：7 to 14 days after insertion
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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).
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7 to 14 days after insertion
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Number of Participants With More Bleeding Than Typical
時間枠：Up to 10 minutes after insertion
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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.
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Up to 10 minutes after insertion
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Number of Participants With Signs of Infection
時間枠：7 to 10 days after insertion
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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. |
7 to 10 days after insertion
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Number of Participants With Signs of Infection
時間枠：21 to 28 days after insertion
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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. |
21 to 28 days after insertion
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Kathleen H Sienko, PhD、Associate Professor
- 主任研究者：Carrie L Bell, MD、Assistant Professor
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SubQAssist0001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Implant insertion deviceの臨床試験
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Ohio State UniversityMedical University of South Carolina; Northwestern University終了しました
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Polares Medical SAPolares Medical, Inc.まだ募集していません
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Seoul National University HospitalHansBiomed Co.,Ltd.積極的、募集していない
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Polares Medical SAPolares Medical, Inc.まだ募集していません
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Abbott Medical Devices完了