Uterine MyomatosisFIBROSACNCT03281460
Efficacy of In-bag Morcellation
A study testing laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation and laparoscopic myomectomy or hysterectomy without any morcellation bag in people with Uterine Myomatosis and Laparoscopy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Myomatosis, Laparoscopy, Hysterectomy, Vaginal
- What is being tested?
- laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation and laparoscopic myomectomy or hysterectomy without any morcellation bag
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2018to 21 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or more
- Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
- Informed and signed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.
The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)
- Conditions
- Uterine Myomatosis, Laparoscopy, Hysterectomy, Vaginal
- Being tested
- laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation, laparoscopic myomectomy or hysterectomy without any morcellation bag
- Keywords
- Hysterectomy, Vaginal, Uterine Myomatosis, Morcellation, Laparoscopy, in-bag morcellation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellationDevice
laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
laparoscopic myomectomy or hysterectomy without any morcellation bagProcedure or surgery
laparoscopic myomectomy or hysterectomy without any morcellation bag
| Study group | Role | What they receive |
|---|---|---|
| with in-bag morcellation | Experimental | with More-cell-Safe AMI bag morcellation Receives: Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation |
| without any morcellation bag | Active comparator | without any morcellation bag Receives: Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smooth muscular cells in the peritoneal fluid after morcellation
After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum
Measured: Day 0 - just after surgery
Secondary outcomes (6)
duration of surgery
Measured: Day 0
morcellation time
Measured: Day 0 - during surgery
peritoneal washing time
Measured: Day 0 - during surgery
residual morcellated tissues weight
Measured: Day 0 - during surgery
bag associated time
Measured: Day 0 - during surgery
ease of use
assessment by a visual analogical scale
Measured: Day 0 - during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start25 Jan 2018
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine MyomatosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gautier CHENE, MD, Principal investigator, Gynaecology Department, Hôpital Femme Mère Enfant, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281460
- Sponsor's protocol ID
- 69HCL16_0714
- Other IDs
- 2017-A01773-50
- Acronym
- FIBROSAC
- Status last verified
- Aug 2025
- First submitted
- 11 Sep 2017
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bensouda-Miguet C, Nohuz E, Cerruto E, Buenerd A, Nadaud B, Moret S, Chene G. Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial. Biomed Res Int. 2021 May 26;2021:6611448. doi: 10.1155/2021/6611448. eCollection 2021.
PubMed 34136570
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of In-bag Morcellation
- ClinicalTrials.gov ID
- NCT03281460
- Acronym / sponsor ID
- FIBROSAC / 69HCL16_0714
- Conditions
- Uterine Myomatosis, Laparoscopy, Hysterectomy, Vaginal
- Keywords
- Hysterectomy, Vaginal, Uterine Myomatosis, Morcellation, Laparoscopy, in-bag morcellation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 13 Sep 2017 (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.
Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.
The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with in-bag morcellation | Experimental | Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellationwith More-cell-Safe AMI bag morcellation |
| without any morcellation bag | Active comparator | Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bagwithout any morcellation bag |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 18 years or more
- Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
- Informed and signed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellationlaparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation | Device | with in-bag morcellation |
| laparoscopic myomectomy or hysterectomy without any morcellation baglaparoscopic myomectomy or hysterectomy without any morcellation bag | Procedure or surgery | without any morcellation bag |
Primary outcome
Smooth muscular cells in the peritoneal fluid after morcellation
Time frame: Day 0 - just after surgery
After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum
6 secondary outcomes
duration of surgery
Time frame: Day 0
morcellation time
Time frame: Day 0 - during surgery
peritoneal washing time
Time frame: Day 0 - during surgery
residual morcellated tissues weight
Time frame: Day 0 - during surgery
bag associated time
Time frame: Day 0 - during surgery
ease of use
Time frame: Day 0 - during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Results publication: PubMed 34136570Bensouda-Miguet C, Nohuz E, Cerruto E, Buenerd A, Nadaud B, Moret S, Chene G. Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial. Biomed Res Int. 2021 May 26;2021:6611448. doi: 10.1155/2021/6611448. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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.
Gautier CHENE, MD principal investigator
Gynaecology Department, Hôpital Femme Mère Enfant, HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation and laparoscopic myomectomy or hysterectomy without any morcellation bag in people with Uterine Myomatosis and Laparoscopy, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Smooth muscular cells in the peritoneal fluid after morcellation (time frame: Day 0 - just 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 NCT03281460, which also lists 1 linked publication.
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 2 Sep 2025.