Trial Outcomes & Findings for Uterine Filling Pressure in Hysteroscopy (NCT NCT04550429)
NCT ID: NCT04550429
Last Updated: 2026-04-30
Results Overview
Noting if pressure needed changing by surgeon during the procedure.
TERMINATED
NA
35 participants
Through study completion, an average of 1 year
2026-04-30
Participant Flow
Thirty-five patients enrolled in the study by signing the informed consent form. 11 participants were assigned to the control group, and 8 participants to the experimental group.
Participant milestones
| Measure |
60 mmHg MyoSure Hysteroscopic Morcellator Device
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.
MyoSure Hysteroscopic Morcellator Device: This device is normally used for this procedure, but I included it as intervention because we will lower the pressure for one arm of the study (treatment) and keep the pressure in the other arm (control) as the standard of care.
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80 mmHg MyoSure Hysteroscopic Morcellator Device
This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study
MyoSure Hysteroscopic Morcellator Device: This device is normally used for this procedure, but I included it as intervention because we will lower the pressure for one arm of the study (treatment) and keep the pressure in the other arm (control) as the standard of care.
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|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
No baseline or demographic data were collected for this outcome. Consistent exposure to assigned intrauterine pressures could not be achieved due to uncontrollable intraoperative fluctuations. Without stable pressure in either group, data would be invalid. As no participants received stable exposure and data collection was never initiated, no baseline characteristics were recorded in the study database. Therefore, no data are available to summarize or report.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report.
Duration of surgery to assess if pressure changes affects length of surgery time.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report.
Specimen will be sent to pathology to note weight in grams.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report.
Volume of normal saline used during procedure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report.
Noting yes or no if Lasix was administered post-operatively.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report.
Noting if pressure needed changing by surgeon during the procedure.
Outcome measures
Outcome data not reported
Adverse Events
60 mmHg MyoSure Hysteroscopic Morcellator Device
80 mmHg MyoSure Hysteroscopic Morcellator Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place