Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy

NCT ID: NCT04423172

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

Study Completion Date

2022-12-26

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

the new tissue containment system

Intervention Type DEVICE

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.

Open group

Without using any procteciton system during Laprascopic Hysterectomy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jing Liang

OTHER

Sponsor Role lead

Responsible Party

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Jing Liang

professor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Jun Yang, MD

Role: CONTACT

8684206115

Other Identifiers

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NTCS-LH

Identifier Type: -

Identifier Source: org_study_id

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