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

NCT ID: NCT04406597

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2024-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Ovary Neoplasm Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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the New Tissue Containment System group

Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy

Group Type EXPERIMENTAL

the New Tissue Containment System

Intervention Type DEVICE

Laparoscopic Ovarian Cystectomy using the New Tissue Containment System

Open group

Without any protection system during Laparoscopic Ovarian Cystectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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the New Tissue Containment System

Laparoscopic Ovarian Cystectomy using the New Tissue Containment System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jing Liang

Vice Director of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yao Wang, MD

Role: CONTACT

8684206115

Facility Contacts

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fang zhao

Role: primary

08601084206115

Other Identifiers

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NTCS-LOC

Identifier Type: -

Identifier Source: org_study_id

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