- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04423172
Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy
8. juni 2020 opdateret af: Jing Liang
Safety, Efficacy and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laprascopic Hysterectomy
The study is designed to evaluate the safety, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy.
Pre- and perimenopausal women undergoing laparoscopic hysterectomy.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jun Yang, MD
- Telefonnummer: 8684206115
- E-mail: kong-yj@163.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Pre- and Peri-menopausal woman patient age 18-65 years
- Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for laparoscopic hysterectomy.
- Normal Pap smear result within one year
- The uterus is larger than 12 weeks of gestation
- The body mass index of the patients is 18.5-27.9kg/m2
- Signed informed consent form
Exclusion Criteria:
- Women with Known or suspected malignancy
- patients during pregnancy and lactation
- Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
- Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
- Patients who are known to have participated in any other clinical trial within 3 months
- Patients who cannot sign informed consent
- Patients with acute stage infection of the reproductive system or other sites
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Using the New Tissue Containment System group
using the new tissue containment system during Laparoscopic Hysterectomy.
The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina.
The divice is named the new tissue containment system.
|
Using the new tissue containment system during Laparoscopic hysterectomy.
The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina.
The divice is named the new tissue containment system.
|
Ingen indgriben: Open group
Without using any procteciton system during Laprascopic Hysterectomy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The exposure rate
Tidsramme: approximately two years
|
Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
|
approximately two years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean procedure time
Tidsramme: Within one day after the surgery
|
Mean procedure time will be measured by hour/minutes.
|
Within one day after the surgery
|
The probability of failure during in-bag morcellation procedure
Tidsramme: approximately two years
|
Failure is defined as the operator's inability to successfully insert and extract the device.
|
approximately two years
|
Estimated blood loss during operation
Tidsramme: Within one day after the surgery
|
Blood loss during operation will be measured by volume (mL)
|
Within one day after the surgery
|
Post-operative pain
Tidsramme: Within one month after the surgery
|
The patients' post-operative pain will be measured by The Visual Analog Score (VAS).The maximum value is 10 and the minimum is 0. The lower score means a better outcome.
|
Within one month after the surgery
|
Rate of intra- or post-operative complications
Tidsramme: Three months after the surgery
|
Intra or post complications rate (e.g.
urinary, intestinal or nerve injury)
|
Three months after the surgery
|
The Surgeon Task Load Index
Tidsramme: Within one week after the surgery
|
The Surgery Task Load Index will be measured by questionaire.
The maximum value is 120 and the minimum is 0. The higher score means a worse outcome.
|
Within one week after the surgery
|
The Patients' life quality postoperative
Tidsramme: One months after the surgery
|
The patients' life quality will be measured by The World Health Organization's Quality of Life Questionnaire-Brief Version(WHOQOL-BREF).The maximum value is 120 and the minimum is 0. The higher score means a better outcome.
|
One months after the surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
16. juni 2020
Primær færdiggørelse (Forventet)
16. juni 2021
Studieafslutning (Forventet)
26. december 2022
Datoer for studieregistrering
Først indsendt
25. maj 2020
Først indsendt, der opfyldte QC-kriterier
8. juni 2020
Først opslået (Faktiske)
9. juni 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2020
Sidst verificeret
1. maj 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NTCS-LH
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
IPD will to be shared with other researchers after four years
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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