Uterine Filling Pressure in Hysteroscopy

NCT04550429 | Terminated Results FDA Device

• 1 other identifier: STU00211845
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibroids

Outcome Measures

Primary Outcomes (6)

• 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.

  Through study completion, an average of 1 year

• Procedure Time

  Duration of surgery to assess if pressure changes affects length of surgery time.

  Through study completion, an average of 1 year

• Specimen Weight

  Specimen will be sent to pathology to note weight in grams.

  Through study completion, an average of 1 year

• Amount of Fluid

  Volume of normal saline used during procedure.

  Through study completion, an average of 1 year

• Lasix Administered Post-operatively

  Noting yes or no if Lasix was administered post-operatively.

  Through study completion, an average of 1 year

• Change in Pressure Was Needed

  Noting if pressure needed changing by surgeon during the procedure.

  Through study completion, an average of 1 year

Study Arms (2)

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.

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

Device: MyoSure Hysteroscopic Morcellator Device

Interventions

MyoSure Hysteroscopic Morcellator Device DEVICE

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.

60 mmHg MyoSure Hysteroscopic Morcellator Device; 80 mmHg MyoSure Hysteroscopic Morcellator Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids
• Patients under the age of 18

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Center for Comprehensive Gynecology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Dr. Magdy Milad
• Organization: Northwestern Medicine

mmilad@nm.org

3126946447

Study Officials

• Magdy P Milad, MD, MM

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Model Details: 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)

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 16, 2020
• Study Start: August 21, 2020
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)