Ovary NeoplasmNCT04406597
Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy
A study testing the New Tissue Containment System in people with Ovary Neoplasm and Surgery, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovary Neoplasm, 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 2022to 10 Dec 2024
- 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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 086010
fang zhao, 08601084206115
About this study
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
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.
- Conditions
- Ovary Neoplasm, Surgery
- Being tested
- the New Tissue Containment System
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the New Tissue Containment SystemDevice
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
| Study group | Role | What they receive |
|---|---|---|
| the New Tissue Containment System group | Experimental | Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy Receives: Device: the New Tissue Containment System |
| Open group | No intervention | Without any protection system during Laparoscopic Ovarian Cystectomy |
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: End of study - approximately two years
Secondary outcomes (7)
The ovarian reserve function
The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)
Measured: Three months after the surgery
Mean procedure time
Mean procedure time will be measured by hour/minutes.
Measured: Within one week after the surgery
Estimated blood loss during operation
Blood loss during operation will be measured by volume (mL)
Measured: Within one week 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 patients' life quality postoperative: questionaire
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: Three months after the surgery
The Surgery 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 rate of failure during in-bag cystectomy procedure
Failure is defined as the operator's inability to successfully insert and extract the device.
Measured: End of study - 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 posted28 May 2020
- Study start20 May 2022
- Primary completion10 Jun 2023 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary NeoplasmStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Liang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406597
- Sponsor's protocol ID
- NTCS-LOC
- Status last verified
- Oct 2022
- First submitted
- 18 May 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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, 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
- ClinicalTrials.gov ID
- NCT04406597
- Acronym / sponsor ID
- NTCS-LOC
- Conditions
- Ovary Neoplasm, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 28 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the New Tissue Containment System group | Experimental | Device: the New Tissue Containment SystemUsing the New Tissue Containment System during Laparoscopic Ovarian Cystectomy |
| Open group | No intervention | –Without any protection system during Laparoscopic Ovarian Cystectomy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 SystemLaparoscopic Ovarian Cystectomy using the New Tissue Containment System | Device | the New Tissue Containment System group |
Primary outcome
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".
7 secondary outcomes
The ovarian reserve function
Time frame: Three months after the surgery
Mean procedure time
Time frame: Within one week after the surgery
Estimated blood loss during operation
Time frame: Within one week after the surgery
Rate of Intra- or post-operative complications
Time frame: Three months after the surgery
The patients' life quality postoperative: questionaire
Time frame: Three months after the surgery
The Surgery Task Load Index
Time frame: Within one week after the surgery
The rate of failure during in-bag cystectomy procedure
Time frame: End of study - 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.
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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.
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 Ovary Neoplasm and Surgery, run by China-Japan Friendship Hospital 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 7 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 Yao Wang, MD (8684206115, wangyaopumc@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: End of study - 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.