- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03310658
Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study
ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device.
Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Provision of signed and dated Informed Consent Form
- Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
- Female, age 18 years or older
- Indicated for Total Laparoscopic Hysterectomy
Exclusion Criteria:
- HIV
- Hepatitis C
- Diabetics
- Use of systemic corticosteroids
- History of pelvic irradiation
- Active infection
- History of bleeding problems/hemophilia
- Cancer
- Cases in which vaginal cuff closure is intended to be performed robotically
- Pregnant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Enhedens gennemførlighed
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Single Study Site: UANL
As the only study arm, 10 enrolled subjects received vaginal cuff closure with the Zip-Stitch Soft Tissue Closure System as part of Total Laparoscopic Hysterectomy.
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The novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Device Ease of Use
Tidsramme: Immediately following procedure
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Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy.
Assessed following surgery by standardized surgeon interview.
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Immediately following procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Vaginal Cuff Closure
Tidsramme: During procedure.
|
Assessment of quality of vaginal cuff closure following uterine excision.
Performed by surgeon as operative standard of care.
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During procedure.
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Vaginal Cuff Closure Time
Tidsramme: During Procedure.
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Procedural time from uterine excision to successful vaginal cuff closure.
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During Procedure.
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Total Surgical Time
Tidsramme: During Procedure.
|
Total procedural time.
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During Procedure.
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Device Use Learning Curve assessed with a Surgeon Survey
Tidsramme: Assessed immediately following study completion during surgeon survey.
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Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use.
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Assessed immediately following study completion during surgeon survey.
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Sexual Discomfort
Tidsramme: Assessed at 1 and 6 week follow-up visits.
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Measurement of subject discomfort during sexual activity following completion of surgical procedure.
Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain).
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Assessed at 1 and 6 week follow-up visits.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Dan Mazzucco, PhD, ZSX Medical LLC
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ZHP01-1.0
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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