Clinical trial · Interventional
Uterine Filling Pressure in Hysteroscopy
The Effect of Decreased Uterine Filling Pressure in Hysteroscopy, a Double-blind Control Trial
NCT04550429CI-TRIAL-00109927terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroids | Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MyoSure Hysteroscopic Morcellator Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 60 mmHg MyoSure Hysteroscopic Morcellator Device
- description
- 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.
- interventionNames
- Device: MyoSure Hysteroscopic Morcellator Device
- type
- SHAM_COMPARATOR
- label
- 80 mmHg MyoSure Hysteroscopic Morcellator Device
- description
- This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study
- interventionNames
- Device: MyoSure Hysteroscopic Morcellator Device
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids * Patients under the age of 18
References
Publications (0)
Data not yet available
No reference posted for this study.