RecruitingNot ApplicableNCT07032506

Intrauterine Stent Placement Following Hysteroscopic Septum Resection

A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection


Sponsor

Weill Medical College of Cornell University

Enrollment

320 participants

Start Date

May 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hormonal Therapy Agent, a procedure called Intraoperative placement of an inflated intrauterine pediatric foley catheter, and others for people with intrauterine adhesion. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntraoperative placement of an inflated intrauterine pediatric foley catheter

Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.

PROCEDURENo Catheter placement

No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

DRUGHormonal Therapy Agent

2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily)

DRUGOral antibiotics

100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place


Locations(3)

Arkansas Fertility & Gynecology

Little Rock, Arkansas, United States

Weill Cornell Medicine

New York, New York, United States

University Hospitals

Cleveland, Ohio, United States

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NCT07032506


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