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Procedure
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
Awards & highlights
Study Summary
This trial will compare the outcomes of two different pressures used in a Myosure device during hysteroscopy.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount of Fluid
Change in pressure was needed
Lasix administered post-operatively
+3 moreTrial 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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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,196 Total Patients Enrolled
Magdy P Milad, MD, MAPrincipal InvestigatorNorthwestern University
Magdy P Milad, MD, MMPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: 60 mmHg MyoSure Hysteroscopic Morcellator Device
- Group 2: 80 mmHg MyoSure Hysteroscopic Morcellator Device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an opportunity for participants to sign up for this research study?
"Per the information on clinicaltrials.gov, this medical trial is actively recruiting participants. The initial post was published on August 21st 2020 and the last update took place on August 18th 2022."
Answered by AI
How many participants are accepted into this experiment?
"Affirmative, the information hosted on clinicaltrials.gov supports that this medical trial is in need of participants. It was first posted on August 21st 2020 and recently updated on August 18th 2022; 68 people are required to be recruited from 1 centre."
Answered by AI
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