- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423172
Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy
June 8, 2020 updated by: Jing Liang
Safety, Efficacy and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laprascopic Hysterectomy
The study is designed to evaluate the safety, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy.
Pre- and perimenopausal women undergoing laparoscopic hysterectomy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
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
- Name: Jun Yang, MD
- Phone Number: 8684206115
- Email: kong-yj@163.com
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pre- and Peri-menopausal woman patient age 18-65 years
- Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for laparoscopic hysterectomy.
- Normal Pap smear result within one year
- The uterus is larger than 12 weeks of gestation
- The body mass index of the patients is 18.5-27.9kg/m2
- Signed informed consent form
Exclusion Criteria:
- Women with Known or suspected malignancy
- 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
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Using the New Tissue Containment System group
using the new tissue containment system during Laparoscopic Hysterectomy.
The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina.
The divice is named the new tissue containment system.
|
Using the new tissue containment system during Laparoscopic hysterectomy.
The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina.
The divice is named the new tissue containment system.
|
No Intervention: Open group
Without using any procteciton system during Laprascopic Hysterectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The exposure rate
Time Frame: approximately two years
|
Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
|
approximately two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean procedure time
Time Frame: Within one day after the surgery
|
Mean procedure time will be measured by hour/minutes.
|
Within one day after the surgery
|
The probability of failure during in-bag morcellation procedure
Time Frame: approximately two years
|
Failure is defined as the operator's inability to successfully insert and extract the device.
|
approximately two years
|
Estimated blood loss during operation
Time Frame: Within one day after the surgery
|
Blood loss during operation will be measured by volume (mL)
|
Within one day after the surgery
|
Post-operative pain
Time Frame: Within one month after the surgery
|
The patients' post-operative pain will be measured by The Visual Analog Score (VAS).The maximum value is 10 and the minimum is 0. The lower score means a better outcome.
|
Within one month 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 Surgeon 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 Patients' life quality postoperative
Time Frame: One 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.
|
One months after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
June 16, 2020
Primary Completion (Anticipated)
June 16, 2021
Study Completion (Anticipated)
December 26, 2022
Study Registration Dates
First Submitted
May 25, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 8, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NTCS-LH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
IPD will to be shared with other researchers after four years
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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