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New surgical bag aims to keep fibroids contained during keyhole surgery

NCT ID NCT07474688

Disease control Sponsor: China-Japan Friendship Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a fully enclosed protective bag used during laparoscopic myomectomy to remove uterine fibroids. The bag is meant to keep fibroid tissue completely isolated, preventing any leakage or spread during the procedure. Twenty women aged 28-46 with fibroids 6-10 cm will be evaluated for bag integrity, operative time, blood loss, and recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fully enclosed protective bag device
What this could lead to
If successful, this technique could reduce the risk of fibroid tissue spreading during surgery, making laparoscopic myomectomy safer.
What could go wrong
This is a small, early observational study with only 20 participants. The device may not prevent all leakage, and results may not apply to larger or more complex fibroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

28 to 46 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

leiomyoma uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uterine fibroids (leiomyoma)

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    Beijing, No. 2, Xinghua East Street, Chaoyang District, 100020, China

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