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

J

Jing Liang

Status

Unknown

Conditions

Gynecologic Surgery

Treatments

Device: the new tissue containment system

Study type

Interventional

Funder types

Other

Identifiers

NCT04423172
NTCS-LH

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

Using the New Tissue Containment System group
Experimental group
Description:
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.
Treatment:
Device: the new tissue containment system
Open group
No Intervention group
Description:
Without using any procteciton system during Laprascopic Hysterectomy.

Trial contacts and locations

0

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Central trial contact

Jun Yang, MD

Data sourced from clinicaltrials.gov

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