FibroidsNCT04550429
Uterine Filling Pressure in Hysteroscopy
A study testing MyoSure Hysteroscopic Morcellator Device in people with Fibroids, run by Northwestern University at 1 site in United States.
Trial summary
The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a MyoSure device with a pressure of 60 mmHg to those using the standard of 80 mmHg. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroids
- What is being tested?
- MyoSure Hysteroscopic Morcellator Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 11 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients electing for operative or diagnostic hysteroscopy procedures for management of polyps and fibroids
- Age equal to or greater than 18
- Ability to understand and willingness to sign consent form. Non-English speaking patients will be included in this study
Who cannot join
- Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Comprehensive Gynecology
Chicago, Illinois, 60611
About this study
Official title: The Effect of Decreased Uterine Filling Pressure in Hysteroscopy, a Double-blind Control Trial
The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a MyoSure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.
Read the detailed description
An a priori sample size calculation was completed. To achieve 80% power and an alpha of .05, the study team needed a sample size of 68 total with 34 participants in each group.The study will be a double-blind randomized control trial. Patients will be recruited based on surgery type (hysteroscopy) and consented using a written consent by the research coordinator with sufficient time to ensure patient comprehension and allow for any questions. The consent process will happen in the pre-operative appointment. Participants will then be randomized to either the standard of care of 80mmHg or the experimental pressure of 60 mmHg for uterine filling pressure via an automated randomization program. The physician performing the surgery and the patient will not know what group they are assigned to. The procedure involved in the study will be hysteroscopy. Hysteroscopy is a procedure that is used to diagnose and sometimes treat intrauterine pathologies. In order to visualize the uterus, pressurized saline is used to distend the uterus.
In this study, the specific hysteroscopic procedure will involve the removal of uterine fibroids with a MyoSure Hysteroscopic Morcellator device. These tissue samples will be collected and sent to Pathology to be weighed. During the surgery, the surgeon will be able to request an adjustment pressure if visualization is not adequate. Physicians will start with a pressure of 80mmHg. Once physician is ready to introduce the MyoSure hysteroscopy device, the pressure level will then be randomized. During the procedure, monitoring will be done by anesthesia through the use of pulse oximetry and measurement of vitals during the Monitored Anesthesia Care. There is also real-time monitoring of hysteroscopic fluid deficit via the fluid management system that is attached to the hysteroscopic pump. Fluid deficit can also be confirmed by the nurse who manually counts the amount of fluid used during the procedure. Per policy, once a 2500mL deficit is reached, the procedure is terminated. After the surgery, the surgeon will fill out a questionnaire that measures the outcomes of surgeon satisfaction and visualization during the procedure. The other end points of procedure time, specimen weight, volume of normal saline used, any changes in pressure needed during the surgery, and whether the patient required Lasix post-operatively will also be collected at this time.
- Conditions
- Fibroids
- Being tested
- MyoSure Hysteroscopic Morcellator Device
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoSure Hysteroscopic Morcellator DeviceDevice
This device is normally used for this procedure, but the investigators included it as an intervention because the pressure will be lowered for one arm of the study (treatment) and the pressure in the other arm will be remain unchanged (control) as the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 60 mmHg MyoSure Hysteroscopic Morcellator Device | Active comparator | The rationale for this experimental arm is that the pressurization can result in excess fluid being absorbed by the patient without a substantial benefit to surgical outcome. Minimizing the pressure from 80 mmHg (which is standard of care) to 60 mmHg used during this procedure may optimize outcome without compromising visualization of the surgeon. The research procedure will take place in the operating room of the minimally invasive gynecologic surgery department. Receives: Device: MyoSure Hysteroscopic Morcellator Device |
| 80 mmHg MyoSure Hysteroscopic Morcellator Device | Sham comparator | This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study Receives: Device: MyoSure Hysteroscopic Morcellator Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Survey to Assess Visualization
Determining whether lowering pressure on hysteroscopic morcellator during hysteroscopy, using block randomization, affects visualization for surgeon using a post-op survey for surgeon to gauge outcomes.
Measured: Through study completion, an average of 1 year
Procedure Time
Duration of surgery to assess if pressure changes affects length of surgery time.
Measured: Through study completion, an average of 1 year
Specimen Weight
Specimen will be sent to pathology to note weight in grams.
Measured: Through study completion, an average of 1 year
Amount of Fluid
Volume of normal saline used during procedure.
Measured: Through study completion, an average of 1 year
Lasix Administered Post-operatively
Noting yes or no if Lasix was administered post-operatively.
Measured: Through study completion, an average of 1 year
Change in Pressure Was Needed
Noting if pressure needed changing by surgeon during the procedure.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start21 Aug 2020
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Why it stopped: Data collection was not possible due to failure to maintain assigned uterine pressure from uncontrollable intraoperative fluctuations. Without stable pressure in either group, data would be invalid.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibroidsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using block randomization to divide patients into two groups using two different levels of pressure on the hysteroscopic morcellator: experimental group (those receiving 60 mmHg of pressure) and control group (those receiving 80 mmHg of pressure)
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Milad, MD, Northwestern University
- Investigators
- Magdy P Milad, MD, MM, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550429
- Sponsor's protocol ID
- STU00211845
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2020
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Participant data will only involve consent forms, which will be stored in a locked cabinet in the research coordinators office along with the updated protocol and other study materials. The survey for the surgeon performing the procedure will be stored in the same place and used for data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Decreased Uterine Filling Pressure in Hysteroscopy, a Double-blind Control Trial
- ClinicalTrials.gov ID
- NCT04550429
- Acronym / sponsor ID
- STU00211845
- Conditions
- Fibroids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collection was not possible due to failure to maintain assigned uterine pressure from uncontrollable intraoperative fluctuations. Without stable pressure in either group, data would be invalid.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 30 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a MyoSure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.
Detailed description
An a priori sample size calculation was completed. To achieve 80% power and an alpha of .05, the study team needed a sample size of 68 total with 34 participants in each group.The study will be a double-blind randomized control trial. Patients will be recruited based on surgery type (hysteroscopy) and consented using a written consent by the research coordinator with sufficient time to ensure patient comprehension and allow for any questions. The consent process will happen in the pre-operative appointment. Participants will then be randomized to either the standard of care of 80mmHg or the experimental pressure of 60 mmHg for uterine filling pressure via an automated randomization program. The physician performing the surgery and the patient will not know what group they are assigned to. The procedure involved in the study will be hysteroscopy. Hysteroscopy is a procedure that is used to diagnose and sometimes treat intrauterine pathologies. In order to visualize the uterus, pressurized saline is used to distend the uterus.
In this study, the specific hysteroscopic procedure will involve the removal of uterine fibroids with a MyoSure Hysteroscopic Morcellator device. These tissue samples will be collected and sent to Pathology to be weighed. During the surgery, the surgeon will be able to request an adjustment pressure if visualization is not adequate. Physicians will start with a pressure of 80mmHg. Once physician is ready to introduce the MyoSure hysteroscopy device, the pressure level will then be randomized. During the procedure, monitoring will be done by anesthesia through the use of pulse oximetry and measurement of vitals during the Monitored Anesthesia Care. There is also real-time monitoring of hysteroscopic fluid deficit via the fluid management system that is attached to the hysteroscopic pump. Fluid deficit can also be confirmed by the nurse who manually counts the amount of fluid used during the procedure. Per policy, once a 2500mL deficit is reached, the procedure is terminated. After the surgery, the surgeon will fill out a questionnaire that measures the outcomes of surgeon satisfaction and visualization during the procedure. The other end points of procedure time, specimen weight, volume of normal saline used, any changes in pressure needed during the surgery, and whether the patient required Lasix post-operatively will also be collected at this time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Using block randomization to divide patients into two groups using two different levels of pressure on the hysteroscopic morcellator: experimental group (those receiving 60 mmHg of pressure) and control group (those receiving 80 mmHg of pressure)
| Arm | Type | Receives |
|---|---|---|
| 60 mmHg MyoSure Hysteroscopic Morcellator Device | Active comparator | Device: MyoSure Hysteroscopic Morcellator DeviceThe rationale for this experimental arm is that the pressurization can result in excess fluid being absorbed by the patient without a substantial benefit to surgical outcome. Minimizing the pressure from 80 mmHg (which is standard of care) to 60 mmHg used during this procedure may optimize outcome without compromising visualization of the surgeon. The research procedure will take place in the operating room of the minimally invasive gynecologic surgery department. |
| 80 mmHg MyoSure Hysteroscopic Morcellator Device | Sham comparator | Device: MyoSure Hysteroscopic Morcellator DeviceThis is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study |
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)
- Patients electing for operative or diagnostic hysteroscopy procedures for management of polyps and fibroids
- Age equal to or greater than 18
- Ability to understand and willingness to sign consent form. Non-English speaking patients will be included in this study
Key exclusion criteria (2 listed)
- Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids
- Patients under the age of 18
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 |
|---|---|---|
| MyoSure Hysteroscopic Morcellator DeviceThis device is normally used for this procedure, but the investigators included it as an intervention because the pressure will be lowered for one arm of the study (treatment) and the pressure in the other arm will be remain unchanged (control) as the standard of care. | Device | 60 mmHg MyoSure Hysteroscopic Morcellator Device, 80 mmHg MyoSure Hysteroscopic Morcellator Device |
Primary outcome
Physician Survey to Assess Visualization
Time frame: Through study completion, an average of 1 year
Determining whether lowering pressure on hysteroscopic morcellator during hysteroscopy, using block randomization, affects visualization for surgeon using a post-op survey for surgeon to gauge outcomes.
Procedure Time
Time frame: Through study completion, an average of 1 year
Duration of surgery to assess if pressure changes affects length of surgery time.
Specimen Weight
Time frame: Through study completion, an average of 1 year
Specimen will be sent to pathology to note weight in grams.
Amount of Fluid
Time frame: Through study completion, an average of 1 year
Volume of normal saline used during procedure.
Lasix Administered Post-operatively
Time frame: Through study completion, an average of 1 year
Noting yes or no if Lasix was administered post-operatively.
Change in Pressure Was Needed
Time frame: Through study completion, an average of 1 year
Noting if pressure needed changing by surgeon during the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Participant data will only involve consent forms, which will be stored in a locked cabinet in the research coordinators office along with the updated protocol and other study materials. The survey for the surgeon performing the procedure will be stored in the same place and used for data analysis.
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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.
Magdy P Milad, MD, MM principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoSure Hysteroscopic Morcellator Device in people with Fibroids, run by Northwestern University at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 30 Apr 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physician Survey to Assess Visualization (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. 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 30 Apr 2026.