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NOT YET RECRUITING
NCT07032506
NA

Intrauterine Stent Placement Following Hysteroscopic Septum Resection

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2026-03

Completion Date

2031-12-31

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

PROCEDURE

Intraoperative 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.

PROCEDURE

No Catheter placement

No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

DRUG

Hormonal 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)

DRUG

Oral 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