Hysteroscopic Morcellation for Uterine Fibroids

N/A

Waitlist Available

Led By Magdy P Milad, MD, MA

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial compares two pressure settings (60 mmHg vs. 80 mmHg) for a device used to remove uterine fibroids during hysteroscopy. It aims to find out which pressure setting provides better visualization and outcomes for patients undergoing this procedure.

Eligible Conditions

Uterine Fibroids

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Amount of Fluid

Change in pressure was needed

Lasix administered post-operatively

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 60 mmHg MyoSure Hysteroscopic Morcellator DeviceActive Control1 Intervention

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.

Group II: 80 mmHg MyoSure Hysteroscopic Morcellator DevicePlacebo Group1 Intervention

This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study

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