NCT04406597

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

May 18, 2020

Last Update Submit

October 25, 2022

Conditions

Ovary NeoplasmSurgery

Outcome Measures

Primary Outcomes (1)

  • The exposure rate

    • 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 Outcomes (7)

  • The ovarian reserve function

    Three months after the surgery

  • Mean procedure time

    Within one week after the surgery

  • Estimated blood loss during operation

    Within one week after the surgery

  • Rate of Intra- or post-operative complications

    Three months after the surgery

  • The patients' life quality postoperative: questionaire

    Three months after the surgery

  • +2 more secondary outcomes

Study Arms (2)

the New Tissue Containment System group

EXPERIMENTAL

Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy

Device: the New Tissue Containment System

Open group

NO INTERVENTION

Without any protection system during Laparoscopic Ovarian Cystectomy

Interventions

the New Tissue Containment SystemDEVICE

Laparoscopic Ovarian Cystectomy using the New Tissue Containment System

the New Tissue Containment System group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 086010, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Yao Wang, MD

CONTACT

8684206115wangyaopumc@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 28, 2020

Study Start

May 20, 2022

Primary Completion

June 10, 2023

Study Completion

December 10, 2024

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations

CN(1)