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

NCT04423172 | Unknown

• 1 other identifier: NTCS-LH
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gynecologic Surgery

Keywords

morcellation; laparoscopic surgery; hysterectomy

Outcome Measures

Primary Outcomes (1)

• The exposure rate

  Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".

  approximately two years

Secondary Outcomes (7)

• Mean procedure time

  Within one day after the surgery

• The probability of failure during in-bag morcellation procedure

  approximately two years

• Estimated blood loss during operation

  Within one day after the surgery

• Post-operative pain

  Within one month after the surgery

• Rate of intra- or post-operative complications

  Three months after the surgery

Study Arms (2)

Using the New Tissue Containment System group

EXPERIMENTAL

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.

Device: the new tissue containment system

Open group

NO INTERVENTION

Without using any procteciton system during Laprascopic Hysterectomy.

Interventions

the new tissue containment system 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.

Using the New Tissue Containment System group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jing Liang: lead

Central Study Contacts

Jun Yang, MD

CONTACT

8684206115; kong-yj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 9, 2020
• Study Start: June 16, 2020
• Primary Completion: June 16, 2021
• Study Completion: December 26, 2022
• Last Updated: June 9, 2020

Record last verified: 2020-05