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Carboprost for Fibroid Resection

Q: Is the research team currently seeking participants to join this trial?

<p>As per clinicaltrials.gov, the search for participants is ongoing; the trial was initially published on July 12th 2022 and has been recently updated as of August 24th 2022.</p>

Q: How many volunteers are participating in this trial?

<p>Yes, the data visible on clinicaltrials.gov reveals that this medical investigation is currently seeking participants. The study was first announced on July 12th 2022 and the most recent edit happened August 24th of the same year. 30 patients need to be enrolled across a single site.</p>

Phase < 1

Recruiting

Led By Magdy p Milad, MD, MS

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Patients scheduled to undergo myomectomy with a surgeon in the division of Minimally Invasive Gynecologic Surgery

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 2 years

Awards & highlights

Study Summary

This trial will test if a low dose of carboprost helps remove fibroids during surgery.

Who is the study for?

This trial is for patients planning to have fibroid removal surgery with a specific team of surgeons and who can understand and sign consent. It's not for those who've taken certain labor-inducing drugs, have active heart or lung disease, PID, severe anemia, diabetes, jaundice, epilepsy, or kidney/liver problems.Check my eligibility

What is being tested?

The study is testing whether a low dose of Carboprost (Hemabate) makes it easier to remove uterine fibroids during surgery. The focus is on using less than the usual amount of this medication to see if it still helps in the surgical process.See study design

What are the potential side effects?

Carboprost may cause side effects like nausea and vomiting, diarrhea, fever or chills; it might also induce strong contractions of the uterus which could be uncomfortable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a myomectomy with a minimally invasive gynecologic surgeon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Carboprost

Secondary outcome measures

To quantitatively assess the efficiency of fibroid resection after carboprost administration by analyzing the video recording from surgery

Trial Design

1Treatment groups

Experimental Treatment

Group I: HemabateExperimental Treatment1 Intervention

Dilute the 250mcg/mL vial with 25mL saline to create a solution of 10mcg/mL, and inject no more than 10mL of diluted solution at the base of the fibroid. The route of administration depends on the location of the fibroid.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,201 Total Patients Enrolled

Magdy p Milad, MD, MSPrincipal InvestigatorNorthwestern University, Northwestern Memorial Hopsital

Media Library

Carboprost Tromethamine Clinical Trial Eligibility Overview. Trial Name: NCT05518812 — Phase < 1

Uterine Fibroids Research Study Groups: Hemabate

Uterine Fibroids Clinical Trial 2023: Carboprost Tromethamine Highlights & Side Effects. Trial Name: NCT05518812 — Phase < 1

Carboprost Tromethamine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518812 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team currently seeking participants to join this trial?

"As per clinicaltrials.gov, the search for participants is ongoing; the trial was initially published on July 12th 2022 and has been recently updated as of August 24th 2022."

Answered by AI

How many volunteers are participating in this trial?

"Yes, the data visible on clinicaltrials.gov reveals that this medical investigation is currently seeking participants. The study was first announced on July 12th 2022 and the most recent edit happened August 24th of the same year. 30 patients need to be enrolled across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Carboprost (Hemabate) for Fibroid Resection

Magdy Milad, MD 2022. "Carboprost (Hemabate) for Fibroid Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05518812.

All > Uterine Fibroids