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

25 oktober 2020 bijgewerkt door: Ibrahim Mohedas, University of Michigan

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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

9

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • University of Michigan

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 49 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Implant insertion device
Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Andere namen:
  • SubQ Assist

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Implant Depth: Distal End
Tijdsspanne: 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.
Up to 60 minutes after insertion
Implant Depth: Proximal End
Tijdsspanne: 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.
Up to 60 minutes after insertion
Implant Palpability
Tijdsspanne: 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.
Up to 15 minutes after insertion

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Bruising
Tijdsspanne: 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.
Up to 15 minutes after insertion.
Presence of Bruising
Tijdsspanne: 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).
7 to 14 days after insertion
Number of Participants With More Bleeding Than Typical
Tijdsspanne: 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.
Up to 10 minutes after insertion
Number of Participants With Signs of Infection
Tijdsspanne: 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.
7 to 10 days after insertion
Number of Participants With Signs of Infection
Tijdsspanne: 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.
21 to 28 days after insertion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Medewerkers

Grand Challenges Canada
Michigan Translation and Commercialization for Life Sciences Hub
VentureWell
Unite for Sight

Onderzoekers

  • Hoofdonderzoeker: Kathleen H Sienko, PhD, Associate professor
  • Hoofdonderzoeker: Carrie L Bell, MD, Assistant Professor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 november 2018

Primaire voltooiing (Werkelijk)

1 november 2019

Studie voltooiing (Werkelijk)

1 december 2019

Studieregistratiedata

Eerst ingediend

3 augustus 2018

Eerst ingediend dat voldeed aan de QC-criteria

7 augustus 2018

Eerst geplaatst (Werkelijk)

8 augustus 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 november 2020

Laatste update ingediend die voldeed aan QC-criteria

25 oktober 2020

Laatst geverifieerd

1 oktober 2020

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • SubQAssist0001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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