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

NCT04392674 | Unknown

• 1 other identifier: NTCS-20200508
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gynecologic Surgery

Keywords

morcellation; myomectomy; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The probability of failure during in-bag morcellation procedure

  approximately two years

• Mean procedure time

  approximately two years

• Estimated blood loss during operation

  approximately two years

• Post-operative pain

  approximately two years

• Intra- or post-operative complications

  approximately two years

Study Arms (1)

using the new tissue containment system

EXPERIMENTAL

using the new tissue containment system during Laparoscopic myomectomy morcellation

Device: the new tissue containment system

Interventions

the new tissue containment system DEVICE

using the new tissue containment system during Laparoscopic myomectomy morcellation

using the new tissue containment system

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jing Liang: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

Central Study Contacts

Fang Zhao, MD

CONTACT

861084206115; fangzhaow@163.com

Yao Wang, PHD

CONTACT

861084205983

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: May 20, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 20, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

CN (1)