Clinical trial · Observational
Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
NCT07486622CI-TRIAL-00106107active not recruitingClinicalTrials.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)
This study evaluates the feasibility, safety, and efficiency of transvaginal in-bag electromechanical morcellation for specimen extraction in patients undergoing total laparoscopic hysterectomy for large uteri.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomyosis | — | UNRESOLVED | — |
| Enlarged Uterus | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Transvaginal In-Bag Morcellation Group
Primary outcomes (1)
- measure
- Containment bag integrity
- timeFrame
- Immediately after specimen extraction
- description
- Integrity of the specimen containment bag assessed using methylene blue leakage testing following specimen extraction
Secondary outcomes (5)
- measure
- Specimen extraction time
- timeFrame
- Periprocedurally
- description
- Duration required to complete transvaginal in-bag electromechanical morcellation and removal of the uterine specimen, measured in minutes.
- measure
- Total operative time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 38 Years
- Maximum age
- 52 Years
Show eligibility criteria text
Inclusion Criteria: Female patients aged 38 to 52 years Planned to undergo total laparoscopic hysterectomy Uterine size greater than 12 weeks gestational size based on preoperative imaging Eligible for transvaginal specimen extraction Able and willing to provide written informed consent Exclusion Criteria: Advanced gynecologic malignancy Severe pelvic obliteration preventing transvaginal access Contraindication to laparoscopic surgery Pregnancy Inability or unwillingness to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.