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

Primary Purpose

Ovary Neoplasm, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the New Tissue Containment System
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovary Neoplasm

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the New Tissue Containment System group

Open group

Arm Description

Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy

Without any protection system during Laparoscopic Ovarian Cystectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The ovarian reserve function
The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)
Mean procedure time
Mean procedure time will be measured by hour/minutes.
Estimated blood loss during operation
Blood loss during operation will be measured by volume (mL)
Rate of Intra- or post-operative complications
Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
The patients' life quality postoperative: questionaire
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.
The Surgery Task Load Index
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.
The rate of failure during in-bag cystectomy procedure
Failure is defined as the operator's inability to successfully insert and extract the device.

Full Information

First Posted
May 18, 2020
Last Updated
October 25, 2022
Sponsor
China-Japan Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04406597
Brief Title
Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovary Neoplasm, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the New Tissue Containment System group
Arm Type
Experimental
Arm Description
Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy
Arm Title
Open group
Arm Type
No Intervention
Arm Description
Without any protection system during Laparoscopic Ovarian Cystectomy
Intervention Type
Device
Intervention Name(s)
the New Tissue Containment System
Intervention Description
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
Primary Outcome Measure Information:
Title
The exposure rate
Description
• Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
Time Frame
End of study - approximately two years
Secondary Outcome Measure Information:
Title
The ovarian reserve function
Description
The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)
Time Frame
Three months after the surgery
Title
Mean procedure time
Description
Mean procedure time will be measured by hour/minutes.
Time Frame
Within one week after the surgery
Title
Estimated blood loss during operation
Description
Blood loss during operation will be measured by volume (mL)
Time Frame
Within one week after the surgery
Title
Rate of Intra- or post-operative complications
Description
Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Time Frame
Three months after the surgery
Title
The patients' life quality postoperative: questionaire
Description
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.
Time Frame
Three months after the surgery
Title
The Surgery Task Load Index
Description
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.
Time Frame
Within one week after the surgery
Title
The rate of failure during in-bag cystectomy procedure
Description
Failure is defined as the operator's inability to successfully insert and extract the device.
Time Frame
End of study - approximately two years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Wang, MD
Phone
8684206115
Email
wangyaopumc@163.com
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
086010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fang zhao
Phone
08601084206115

12. IPD Sharing Statement

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

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