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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- University of Michigan
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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.
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Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Implant Depth: Distal End
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants With Bruising
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kathleen H Sienko, PhD, Associate professor
- Hauptermittler: Carrie L Bell, MD, Assistant Professor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- SubQAssist0001
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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