Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy

October 25, 2022 updated by: Jing Liang, China-Japan Friendship Hospital

Safety, Effectiveness and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Ovarian Cystectomy

The study is designed to evaluate the safety, effectiveness and operability of performing in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic ovarian cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 086010
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • fang zhao
          • Phone Number: 08601084206115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal woman patient age 18-45 years
  • Women with regular period
  • Women with ovarian neoplasm (size: 3-10cm)
  • Laparoscopic surgery required
  • Body mass index 18.5-27.9kg/m2
  • Subject able to comprehend and give informed consent for participation in this study
  • Signed informed consent form

Exclusion Criteria:

  • Patient is not considered suitable for a laparoscopic ovarian cystectomy procedure
  • The ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free
  • Women with Polycystic ovary syndrome
  • Baseline AMH less than 0.5ng / mL
  • Known to have participated in any other clinical trials or hormone therapy within 3 months
  • Women during pregnancy and lactation
  • Women in acute stage infection of reproductive system or other parts
  • Women combined with severe central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease, Cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders contraindicating laparoscopic surgery
  • Women with known or suspected poor compliance who cannot complete the trial
  • Those who can not sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: the New Tissue Containment System group
Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy
Device: the New Tissue Containment System
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
NO_INTERVENTION: Open group
Without any protection system during Laparoscopic Ovarian Cystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The exposure rate
Time Frame: End of study - approximately two years
• Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
End of study - approximately two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ovarian reserve function
Time Frame: Three months after the surgery
The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)
Three months after the surgery
Mean procedure time
Time Frame: Within one week after the surgery
Mean procedure time will be measured by hour/minutes.
Within one week after the surgery
Estimated blood loss during operation
Time Frame: Within one week after the surgery
Blood loss during operation will be measured by volume (mL)
Within one week after the surgery
Rate of Intra- or post-operative complications
Time Frame: Three months after the surgery
Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Three months after the surgery
The patients' life quality postoperative: questionaire
Time Frame: Three months after the surgery
The patients' life quality will be measured by The World Health Organization's Quality of Life Questionnaire-Brief Version（WHOQOL-BREF).The maximum value is 120 and the minimum is 0. The higher score means a better outcome.
Three months after the surgery
The Surgery Task Load Index
Time Frame: Within one week after the surgery
The Surgery Task Load Index will be measured by questionaire. The maximum value is 120 and the minimum is 0. The higher score means a worse outcome.
Within one week after the surgery
The rate of failure during in-bag cystectomy procedure
Time Frame: End of study - approximately two years
Failure is defined as the operator's inability to successfully insert and extract the device.
End of study - approximately two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 20, 2022

Primary Completion (ANTICIPATED)

June 10, 2023

Study Completion (ANTICIPATED)

December 10, 2024

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 24, 2020

First Posted (ACTUAL)

May 28, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTCS-LOC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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