Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04406597|
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovary Neoplasm Surgery||Device: the New Tissue Containment System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Estimated Study Start Date :||June 10, 2020|
|Estimated Primary Completion Date :||June 10, 2021|
|Estimated Study Completion Date :||December 10, 2022|
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
- 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".
- 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)
- Mean procedure time [ Time Frame: Within one week after the surgery ]Mean procedure time will be measured by hour/minutes.
- Estimated blood loss during operation [ Time Frame: Within one week after the surgery ]Blood loss during operation will be measured by volume (mL)
- 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)
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406597
|Contact: Yao Wang, MDfirstname.lastname@example.org|