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

25. oktober 2020 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

9

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 49 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Implant insertion device
Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
Andre navn:
  • SubQ Assist

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Implant Depth: Distal End
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Bruising
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Michigan

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. november 2018

Primær fullføring (Faktiske)

1. november 2019

Studiet fullført (Faktiske)

1. desember 2019

Datoer for studieregistrering

Først innsendt

3. august 2018

Først innsendt som oppfylte QC-kriteriene

7. august 2018

Først lagt ut (Faktiske)

8. august 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SubQAssist0001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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