Intrauterine Stent Placement After Septum Resection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this open-label randomized trial, people undergoing hysteroscopic resection of a uterine septum (≥50% of the cavity) are assigned to receive an inflated intrauterine foley catheter balloon for 7-10 days with hormonal support or hormonal support alone. Surgical technique (electrocautery vs. sharp resection) is at the surgeon’s discretion, but all participants receive standard postoperative care. The study aims to determine if the balloon stent reduces intrauterine adhesion formation after surgery. Key exclusions include prior uterine surgeries for septum or adhesions and cases where complete septum resection cannot be completed in one procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 and above
* Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process
* Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* History of prior uterine septum resection
* History of prior transmural uterine surgery
* Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions
* Individuals in whom complete septum resection is unable to be performed as a single procedure

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting
• Arkansas Fertility & Gynecology
  Little Rock, Arkansas, United States Not yet recruiting
• University Hospitals
  Cleveland, Ohio, United States Not yet recruiting

Study contacts

• Principal investigator: Glenn Schattman, MD — Weill Medical College of Cornell University
• Study coordinator: Rodriq Stubbs, NP, MSN
• Email: res2011@med.cornell.edu
• Phone: 646-962-3276

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intrauterine Adhesion Prevention With a Uterine Stent After Surgery

  This trial tests whether placing a uterine stent after adhesion surgery helps prevent repeat adhesions in women aged 20–40 with intrauterine adhesions.

  Recruiting The Third Xiangya Hospital of Central South University · Changsha, Hunan · NCT07611474

• A combined 4D ultrasound, hysteroscopic cold-knife plowing, uterine stent, and traditional Chinese medicine approach for intrauterine adhesions

  This project will try a combined care pathway—preoperative 4D ultrasound, hysteroscopic cold-knife adhesion separation, a postoperative uterine stent, and traditional Chinese medicine—to see if it improves outcomes for women aged 18–45 with intrauterine adhesions.

  Recruiting The Third Xiangya Hospital of Central South University · Changsha, Hunan · NCT07421908

• Using Platelet-rich Plasma to Improve Female Fertility

  This study is testing whether injections of platelet-rich plasma can help improve fertility in women dealing with issues like poor ovarian response and repeated implantation failure.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT06645379

• Comparing heparin solution and barrier gel for preventing intrauterine adhesions after surgery

  This study is testing whether a heparin solution or a barrier gel is better at preventing scar tissue in the uterus after surgery for women who have had operative hysteroscopy.

  Recruiting at 2 sites Nadezhda Women's Health Hospital · Sofia, Sofia and 1 other locations · NCT05257213

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.