Uterine FibroidsNCT07486622
Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
An observational study of Uterine Fibroids and Adenomyosis, run by Chang Zhou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 38 to 52 years, women only
- Conditions the study is for
- Uterine Fibroids, Adenomyosis, Enlarged Uterus
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 10 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 38 to 52 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing total laparoscopic hysterectomy for enlarged uteri at a single tertiary medical center. Participants include patients with uterine fibroids or adenomyosis and uterine size greater than 12 weeks gestational size who are suitable for transvaginal specimen extraction.
Who may be able to join
- 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
Who cannot join
- Advanced gynecologic malignancy
- Severe pelvic obliteration preventing transvaginal access
- Contraindication to laparoscopic surgery
- Pregnancy
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, No. 2, Xinghua East Street, Chaoyang District
About this study
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.
Read the detailed description
This single-center prospective study investigates a novel transvaginal specimen extraction technique using a sealed containment bag combined with electromechanical morcellation. The procedure aims to improve specimen extraction efficiency while preventing tissue dissemination during laparoscopic hysterectomy for uteri larger than 12-week gestational size.
- Conditions
- Uterine Fibroids, Adenomyosis, Enlarged Uterus
- Keywords
- Uterine Fibroids, Adenomyosis, Enlarged Uterus
- Medical subject headings
- Leiomyoma, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal In-Bag Morcellation Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Containment bag integrity
Integrity of the specimen containment bag assessed using methylene blue leakage testing following specimen extraction
Measured: Immediately after specimen extraction
Secondary outcomes (5)
Specimen extraction time
Duration required to complete transvaginal in-bag electromechanical morcellation and removal of the uterine specimen, measured in minutes.
Measured: Periprocedurally
Total operative time
Total duration of surgery measured from skin incision to completion of wound closure.
Measured: Immediately after surgery
Estimated intraoperative blood loss
Estimated blood loss recorded during the surgical procedure.
Measured: During surgery
Postoperative complications
Incidence of postoperative complications including infection, fever, or organ injury.
Measured: Up to 30 days postoperatively
Length of postoperative hospital stay
Number of days from surgery until hospital discharge.
Measured: Up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Mar 2025
- Primary completion1 Mar 2026
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang Zhou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486622
- Sponsor's protocol ID
- 2026-LM
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and the potential risk of participant identification in a single-center surgical study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
- ClinicalTrials.gov ID
- NCT07486622
- Acronym / sponsor ID
- 2026-LM
- Conditions
- Uterine Fibroids, Adenomyosis, Enlarged Uterus
- Keywords
- Uterine Fibroids, Adenomyosis, Enlarged Uterus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chang ZhouUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 20 Mar 2026 (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.
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.
Detailed description
This single-center prospective study investigates a novel transvaginal specimen extraction technique using a sealed containment bag combined with electromechanical morcellation. The procedure aims to improve specimen extraction efficiency while preventing tissue dissemination during laparoscopic hysterectomy for uteri larger than 12-week gestational size.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal In-Bag Morcellation Group | – | – |
Who may qualify
- Ages
- 38 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing total laparoscopic hysterectomy for enlarged uteri at a single tertiary medical center. Participants include patients with uterine fibroids or adenomyosis and uterine size greater than 12 weeks gestational size who are suitable for transvaginal specimen extraction.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Advanced gynecologic malignancy
- Severe pelvic obliteration preventing transvaginal access
- Contraindication to laparoscopic surgery
- Pregnancy
- Inability or unwillingness to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Containment bag integrity
Time frame: Immediately after specimen extraction
Integrity of the specimen containment bag assessed using methylene blue leakage testing following specimen extraction
5 secondary outcomes
Specimen extraction time
Time frame: Periprocedurally
Total operative time
Time frame: Immediately after surgery
Estimated intraoperative blood loss
Time frame: During surgery
Postoperative complications
Time frame: Up to 30 days postoperatively
Length of postoperative hospital stay
Time frame: Up to 7 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and the potential risk of participant identification in a single-center surgical study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids and Adenomyosis, run by Chang Zhou 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Containment bag integrity (time frame: Immediately after specimen extraction). 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 20 Mar 2026.