Gynecologic SurgeryNCT04392674
Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation
A study testing the new tissue containment system in people with Gynecologic Surgery, run by Jing Liang at 1 site in China.
Trial summary
The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gynecologic Surgery
- What is being tested?
- the new tissue containment system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2020to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre- and Peri-menopausal woman patient age 18-45 years
- Women with fibroids and indication for laparoscopic myomectomy.
- Normal Pap smear result within one year
- MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm.
- The body mass index of the patients is 18.5-27.9kg/m2
- Signed informed consent form
Who cannot join
- • Women with Known or suspected malignancy
- patients with severe pelvic adhesion found during the operation
- The body mass index of the patient ≥ 28kg/m2
- Diameter of a single uterine fibroid>10cm
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Yao Wang, PHD contact
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Fang Zhao
About this study
Official title: Safety and Efficacy of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Myomectomy Morcellation
The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation
- Conditions
- Gynecologic Surgery
- Being tested
- the new tissue containment system
- Keywords
- morcellation, myomectomy, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the new tissue containment systemDevice
using the new tissue containment system during Laparoscopic myomectomy morcellation
| Study group | Role | What they receive |
|---|---|---|
| using the new tissue containment system | Experimental | using the new tissue containment system during Laparoscopic myomectomy morcellation Receives: Device: the new tissue containment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation
The safety of using the new tissue containment system for cutting and extracting tissue during laparoscopic myomectomy morcellation will be determined by the rate of leakage
Leakage is defined as "disruption of the device (using dye leak testing) or visible tissue dissemination.
Measured: approximately two years
Secondary outcomes (7)
The probability of failure during in-bag morcellation procedure
Failure is defined as the operator's inability to successfully insert and extract the device.
Measured: approximately two years
Mean procedure time
Mean procedure time will be measured by hour/minutes.
Measured: approximately two years
Estimated blood loss during operation
Blood loss during operation will be measured by volume (mL)
Measured: approximately two years
Post-operative pain
Post-operative pain will be measured by Visual Analog Score - VAS
Measured: approximately two years
Intra- or post-operative complications
Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Measured: approximately two years
The Surgeon Task Load Index
The Surgeon Task Load Index be measured by designated Questionnaire.
Measured: approximately two years
The Patients' life quality postoperative
The Patients' life quality postoperative be measured by Questionnaire.
Measured: approximately two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start20 May 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Liang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392674
- Sponsor's protocol ID
- NTCS-20200508
- Status last verified
- Oct 2022
- First submitted
- 14 May 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will to be shared with other researchers after four years
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Myomectomy Morcellation
- ClinicalTrials.gov ID
- NCT04392674
- Acronym / sponsor ID
- NTCS-20200508
- Conditions
- Gynecologic Surgery
- Keywords
- morcellation, myomectomy, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jing LiangUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| using the new tissue containment system | Experimental | Device: the new tissue containment systemusing the new tissue containment system during Laparoscopic myomectomy morcellation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pre- and Peri-menopausal woman patient age 18-45 years
Key exclusion criteria (10 listed)
- • Women with Known or suspected malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the new tissue containment systemusing the new tissue containment system during Laparoscopic myomectomy morcellation | Device | using the new tissue containment system |
Primary outcome
The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation
Time frame: approximately two years
The safety of using the new tissue containment system for cutting and extracting tissue during laparoscopic myomectomy morcellation will be determined by the rate of leakage Leakage is defined as "disruption of the device (using dye leak testing) or visible tissue dissemination.
7 secondary outcomes
The probability of failure during in-bag morcellation procedure
Time frame: approximately two years
Mean procedure time
Time frame: approximately two years
Estimated blood loss during operation
Time frame: approximately two years
Post-operative pain
Time frame: approximately two years
Intra- or post-operative complications
Time frame: approximately two years
The Surgeon Task Load Index
Time frame: approximately two years
The Patients' life quality postoperative
Time frame: approximately two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided. IPD will to be shared with other researchers after four years
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Wang, PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the new tissue containment system in people with Gynecologic Surgery, run by Jing Liang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Zhao, MD (861084206115, fangzhaow@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation (time frame: approximately two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.