Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation

Safety and Efficacy of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Myomectomy Morcellation

The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Surgery
• Intervention / Treatment: Device: the new tissue containment system

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Zhao, MD; Phone Number: 861084206115; Email: fangzhaow@163.com
• Study Contact Backup: Name: Yao Wang, PHD; Phone Number: 861084205983

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Fang Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pre- and Peri-menopausal woman patient age 18-45 years

  • Women with fibroids and indication for laparoscopic myomectomy.
  • Normal Pap smear result within one year
  • MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm.
  • 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 with severe pelvic adhesion found during the operation
  • The body mass index of the patient ≥ 28kg/m2
  • Diameter of a single uterine fibroid>10cm
  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: using the new tissue containment system; using the new tissue containment system during Laparoscopic myomectomy morcellation	Device: the new tissue containment system; using the new tissue containment system during Laparoscopic myomectomy morcellation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation	The safety of using the new tissue containment system for cutting and extracting tissue during laparoscopic myomectomy morcellation will be determined by the rate of leakage Leakage is defined as "disruption of the device (using dye leak testing) or visible tissue dissemination.	approximately two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The probability of failure during in-bag morcellation procedure	Failure is defined as the operator's inability to successfully insert and extract the device.	approximately two years
Mean procedure time	Mean procedure time will be measured by hour/minutes.	approximately two years
Estimated blood loss during operation	Blood loss during operation will be measured by volume (mL)	approximately two years
Post-operative pain	Post-operative pain will be measured by Visual Analog Score - VAS	approximately two years
Intra- or post-operative complications	Intra or post complications rate (e.g. urinary, intestinal or nerve injury)	approximately two years
The Surgeon Task Load Index	The Surgeon Task Load Index be measured by designated Questionnaire.	approximately two years
The Patients' life quality postoperative	The Patients' life quality postoperative be measured by Questionnaire.	approximately two years

Collaborators and Investigators

• Sponsor: Jing Liang

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: laparoscopic surgery; myomectomy; morcellation
• Other Study ID Numbers: NTCS-20200508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will to be shared with other researchers after four years

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No