Clinical trial · Interventional
Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy
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
NCT04406597CI-TRIAL-00061701unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovary Neoplasm | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the New Tissue Containment System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- the New Tissue Containment System group
- description
- Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy
- interventionNames
- Device: the New Tissue Containment System
- type
- NO_INTERVENTION
- label
- Open group
- description
- Without any protection system during Laparoscopic Ovarian Cystectomy
Primary outcomes (1)
- measure
- The exposure rate
- timeFrame
- End of study - approximately two years
- description
- • Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.