Uterine Fibroids (Leiomyoma)NCT07474688
Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure
An observational study of Uterine Fibroids (Leiomyoma), run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the feasibility, safety, and effectiveness of a fully enclosed protective device system in laparoscopic myomectomy to achieve tumor-free protection throughout the entire surgical procedure in women aged 28-46 years diagnosed with uterine fibroids who require… Read more about this study
- Who is it for?
- Ages 28 to 46 years, women only
- Conditions the study is for
- Uterine Fibroids (Leiomyoma)
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2025to 4 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 28 to 46 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population includes female patients with uterine fibroids undergoing laparoscopic myomectomy at a single center between April 2025 and March 2026. Eligible participants are women aged 28 to 46 years with fibroids measuring 6 to 10 cm in diameter and preoperative findings consistent with benign disease.
Who may be able to join
- Female patients aged 28 to 46 years Diagnosis of uterine fibroids confirmed by pelvic ultrasound and magnetic resonance imaging (MRI) Maximum diameter of the dominant fibroid between 6 and 10 cm Scheduled to undergo laparoscopic myomectomy Preoperative evaluation consistent with benign uterine fibroids Able and willing to provide written informed consent
Who cannot join
- Suspicion of uterine malignancy based on imaging findings or clinical assessment Presence of severe systemic disease contraindicating laparoscopic surgery Current 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, 100020
About this study
The goal of this observational study is to evaluate the feasibility, safety, and effectiveness of a fully enclosed protective device system in laparoscopic myomectomy to achieve tumor-free protection throughout the entire surgical procedure in women aged 28-46 years diagnosed with uterine fibroids who require laparoscopic myomectomy.
The main questions it aims to answer are:
Read more
Can the fully enclosed protective device system successfully achieve complete physical isolation of fibroid tissue during laparoscopic myomectomy and morcellation?
Does the use of this device reduce the risk of tissue dissemination or leakage while maintaining acceptable surgical outcomes such as operative time, blood loss, and postoperative recovery?
Participants will undergo laparoscopic myomectomy assisted by the fully enclosed protective device system. During the procedure, participants will:
undergo laparoscopic removal of uterine fibroids using a fully enclosed protective isolation system
have the fibroid dissected and contained within a protective bag during the entire procedure
receive in-bag morcellation or fragmentation of fibroid tissue within a sealed environment
be evaluated for operative outcomes including fibroid size, operative time, intraoperative blood loss, integrity of the protective bag, and postoperative hospital stay
- Conditions
- Uterine Fibroids (Leiomyoma)
- Medical subject headings
- Leiomyoma
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 |
|---|---|---|
| Laparoscopic Myomectomy with Fully Enclosed Protective Device | This cohort includes women diagnosed with uterine fibroids who underwent laparoscopic myomectomy assisted by a fully enclosed protective device system designed to achieve tumor-free protection throughout the entire surgical procedure. During the operation, a specialized high-strength protective bag is introduced into the pelvic cavity before fibroid dissection. The fibroid is separated from the uterine wall while being supported and contained within the protective bag. After removal, the fibroid is completely isolated within the bag, and in-bag morcellation or tissue fragmentation is performed within a sealed environment with an independent pneumoperitoneum, preventing tissue or fluid leakage into the abdominal cavity. The intervention aims to maintain the oncological "tumor-free principle" throughout the procedure, reduce the risk of tissue dissemination, and improve surgical safety during laparoscopic myomectomy. Participants in this cohort were evaluated for surgical outcomes in |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bag integrity and absence of tissue leakage
Assessment of whether the protective bag remains intact without rupture or leakage during the procedure.
Measured: Intraoperative and immediately after surgery
Secondary outcomes (6)
Operative time
Total duration of the surgical procedure
Measured: During surgery
Intraoperative blood loss
Estimated blood loss measured in milliliters
Measured: During surgery
Fibroid size
Maximum diameter of the removed uterine fibroid measured intraoperatively and confirmed by postoperative pathology
Measured: Immediately after surgical removal and confirmed by pathology
Postoperative hospital stay
Length of postoperative hospital stay measured in days
Measured: Perioperatively (from surgery up to hospital discharge, within 7 days)
Postoperative complications
Incidence of postoperative complications such as infection, fever, or pelvic inflammation
Measured: From the day of surgery through 30 days postoperatively
Histopathological diagnosis
Confirmation of the pathological type of removed fibroids by postoperative pathology
Measured: Immediately after surgical removal, confirmed by postoperative pathology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start4 Apr 2025
- Primary completion1 Mar 2026
- Study completion4 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids (Leiomyoma)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Zhou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474688
- Sponsor's protocol ID
- 2024-KY-222
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be publicly shared because the dataset contains identifiable clinical information from a small number of patients treated at a single institution. Public release of these data may increase the risk of patient re-identification and compromise participant privacy. In addition, the study was conducted as a retrospective analysis and the informed consent obtained from participants did not include permission for public sharing of individual-level data. Therefore, to protect patient confidentiality and comply with institutional ethics policies, IPD will not be made publicly available.
Publications
Kho KA, Nezhat C. Parasitic myomas. Obstet Gynecol. 2009 Sep;114(3):611-615. doi: 10.1097/AOG.0b013e3181b2b09a.
PubMed 19701042Cohen SL, Greenberg JA, Wang KC, et al. Risk of dissemination of occult uterine malignancy during laparoscopic morcellation. JAMA. 2014
U.S. Food and Drug Administration. Quantitative Assessment of the Prevalence of Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids. FDA Safety Communication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure
- ClinicalTrials.gov ID
- NCT07474688
- Acronym / sponsor ID
- 2024-KY-222
- Conditions
- Uterine Fibroids (Leiomyoma)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (estimated)
- First posted
- 16 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.
The goal of this observational study is to evaluate the feasibility, safety, and effectiveness of a fully enclosed protective device system in laparoscopic myomectomy to achieve tumor-free protection throughout the entire surgical procedure in women aged 28-46 years diagnosed with uterine fibroids who require laparoscopic myomectomy.
The main questions it aims to answer are:
Can the fully enclosed protective device system successfully achieve complete physical isolation of fibroid tissue during laparoscopic myomectomy and morcellation?
Does the use of this device reduce the risk of tissue dissemination or leakage while maintaining acceptable surgical outcomes such as operative time, blood loss, and postoperative recovery?
Participants will undergo laparoscopic myomectomy assisted by the fully enclosed protective device system. During the procedure, participants will:
undergo laparoscopic removal of uterine fibroids using a fully enclosed protective isolation system
have the fibroid dissected and contained within a protective bag during the entire procedure
receive in-bag morcellation or fragmentation of fibroid tissue within a sealed environment
be evaluated for operative outcomes including fibroid size, operative time, intraoperative blood loss, integrity of the protective bag, and postoperative hospital stay
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Myomectomy with Fully Enclosed Protective Device | – | –This cohort includes women diagnosed with uterine fibroids who underwent laparoscopic myomectomy assisted by a fully enclosed protective device system designed to achieve tumor-free protection throughout the entire surgical procedure. During the operation, a specialized high-strength protective bag is introduced into the pelvic cavity before fibroid dissection. The fibroid is separated from the uterine wall while being supported and contained within the protective bag. After removal, the fibroid is completely isolated within the bag, and in-bag morcellation or tissue fragmentation is performed within a sealed environment with an independent pneumoperitoneum, preventing tissue or fluid leakage into the abdominal cavity. The intervention aims to maintain the oncological "tumor-free principle" throughout the procedure, reduce the risk of tissue dissemination, and improve surgical safety during laparoscopic myomectomy. Participants in this cohort were evaluated for surgical outcomes in |
Who may qualify
- Ages
- 28 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population includes female patients with uterine fibroids undergoing laparoscopic myomectomy at a single center between April 2025 and March 2026. Eligible participants are women aged 28 to 46 years with fibroids measuring 6 to 10 cm in diameter and preoperative findings consistent with benign disease.
Key inclusion criteria (1 listed)
- Female patients aged 28 to 46 years Diagnosis of uterine fibroids confirmed by pelvic ultrasound and magnetic resonance imaging (MRI) Maximum diameter of the dominant fibroid between 6 and 10 cm Scheduled to undergo laparoscopic myomectomy Preoperative evaluation consistent with benign uterine fibroids Able and willing to provide written informed consent
Key exclusion criteria (1 listed)
- Suspicion of uterine malignancy based on imaging findings or clinical assessment Presence of severe systemic disease contraindicating laparoscopic surgery Current 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
Bag integrity and absence of tissue leakage
Time frame: Intraoperative and immediately after surgery
Assessment of whether the protective bag remains intact without rupture or leakage during the procedure.
6 secondary outcomes
Operative time
Time frame: During surgery
Intraoperative blood loss
Time frame: During surgery
Fibroid size
Time frame: Immediately after surgical removal and confirmed by pathology
Postoperative hospital stay
Time frame: Perioperatively (from surgery up to hospital discharge, within 7 days)
Postoperative complications
Time frame: From the day of surgery through 30 days postoperatively
Histopathological diagnosis
Time frame: Immediately after surgical removal, confirmed by postoperative pathology
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 16 Mar 2026.
- Background: PubMed 19701042Kho KA, Nezhat C. Parasitic myomas. Obstet Gynecol. 2009 Sep;114(3):611-615. doi: 10.1097/AOG.0b013e3181b2b09a.
- BackgroundCohen SL, Greenberg JA, Wang KC, et al. Risk of dissemination of occult uterine malignancy during laparoscopic morcellation. JAMA. 2014
- BackgroundU.S. Food and Drug Administration. Quantitative Assessment of the Prevalence of Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids. FDA Safety Communication.
- General information about uterine fibroids and laparoscopic surgeryLink provided by the sponsor.
- China-Japan Friendship Hospital official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be publicly shared because the dataset contains identifiable clinical information from a small number of patients treated at a single institution. Public release of these data may increase the risk of patient re-identification and compromise participant privacy. In addition, the study was conducted as a retrospective analysis and the informed consent obtained from participants did not include permission for public sharing of individual-level data. Therefore, to protect patient confidentiality and comply with institutional ethics policies, IPD will not be made publicly available.
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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 (Leiomyoma), 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 1 inclusion and 1 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 16 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?
Bag integrity and absence of tissue leakage (time frame: Intraoperative and immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474688, which also lists 3 linked publications.
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 16 Mar 2026.