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Bag it up: new device aims to make fibroid surgery safer

NCT ID NCT03281460

Disease control Sponsor: Hospices Civils de Lyon 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether using a special bag during laparoscopic fibroid removal (myomectomy or hysterectomy) can prevent the spread of cells that might be cancerous. Forty-eight women were randomly assigned to have the procedure with or without the bag. Researchers then checked the fluid in the abdomen for any stray muscle cells. The goal is to make minimally invasive fibroid surgery safer.

What this could mean

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

Active substance
More-cell-Safe AMI bag (device) for morcellation
What this could lead to
If it works, this could make laparoscopic fibroid surgery safer by reducing the risk of spreading potentially harmful cells.
What could go wrong
This is a small, early-stage trial with only 48 participants, so results may not apply to all patients. The bag may not prevent all cell spread and could add surgical time.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

48 people

The number who actually took part.

Started

Jan 2018

Finished

Jan 2019

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.

Ages

18 years and older

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: * Women aged 18 years or more * Laparoscopic myomectomy or laparoscopic subtotal hysterectomy * Informed and signed consent Exclusion Criteria: * Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc. * Preoperative risk of leiomyosarcoma or pelvic carcinoma * Pregnancy or desire of pregnancy during the study period * Uterus or myomas weight above 1.000 g * Inability to understand information provided * Not covered by a national health insurance scheme, prisoner or under administrative supervision

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Conditions

The condition(s) this trial relates to.

uterine corpus diffuse leiomyomatosis

As listed by the trial registrant

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

Hysterectomy, vaginal Laparoscopy Uterine myomatosis

Contacts and locations

Locations

  • Gynaecology Department, Hôpital Femme Mère Enfant

    Bron, 69500, France

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