Gynecologic SurgeryNCT04423172
Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy
A study testing the new tissue containment system in people with Gynecologic Surgery, run by Jing Liang.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 120 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2020to 26 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Gynecologic Surgery
- Being tested
- the new tissue containment system
- Keywords
- morcellation, laparoscopic surgery, hysterectomy
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Using the New Tissue Containment System group | Experimental | 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. Receives: Device: the new tissue containment system |
| Open group | No intervention | Without using any procteciton system during Laprascopic Hysterectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The exposure rate
Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
Measured: approximately two years
Secondary outcomes (7)
Mean procedure time
Mean procedure time will be measured by hour/minutes.
Measured: Within one day after the surgery
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
Estimated blood loss during operation
Blood loss during operation will be measured by volume (mL)
Measured: Within one day after the surgery
Post-operative pain
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.
Measured: Within one month after the surgery
Rate of intra- or post-operative complications
Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Measured: Three months after the surgery
The Surgeon Task Load Index
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.
Measured: Within one week after the surgery
The Patients' life quality postoperative
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.
Measured: One months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start16 Jun 2020 (estimated)
- Primary completion16 Jun 2021 (estimated)
- Study completion26 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 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
- NCT04423172
- Sponsor's protocol ID
- NTCS-LH
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 9 Jun 2020
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04423172
- Acronym / sponsor ID
- NTCS-LH
- Conditions
- Gynecologic Surgery
- Keywords
- morcellation, laparoscopic surgery, hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jing LiangUniversity, hospital or other
- Study start
- 16 Jun 2020 (estimated)
- Primary completion
- 16 Jun 2021 (estimated)
- Study completion
- 26 Dec 2022 (estimated)
- First posted
- 9 Jun 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, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women undergoing laparoscopic hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using the New Tissue Containment System group | Experimental | Device: the new tissue containment systemusing 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. |
| Open group | No intervention | –Without using any procteciton system during Laprascopic Hysterectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 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. | Device | Using the New Tissue Containment System group |
Primary outcome
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".
7 secondary outcomes
Mean procedure time
Time frame: Within one day after the surgery
The probability of failure during in-bag morcellation procedure
Time frame: approximately two years
Estimated blood loss during operation
Time frame: Within one day after the surgery
Post-operative pain
Time frame: Within one month after the surgery
Rate of intra- or post-operative complications
Time frame: Three months after the surgery
The Surgeon Task Load Index
Time frame: Within one week after the surgery
The Patients' life quality postoperative
Time frame: One months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- 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.
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.
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 7 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jun Yang, MD (8684206115, kong-yj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The exposure rate (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 9 Jun 2020.