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Search / Trial NCT07032506

Intrauterine Stent Placement Following Hysteroscopic Septum Resection

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jun 14, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Intrauterine Foley Balloon Catheter Stent Uterine Malformations Uterine Septums Hysteroscopic Septoplasty

ClinConnect Summary

This clinical trial is studying a way to prevent scar tissue from forming inside the uterus after surgery to remove a uterine septum, which is a type of internal wall that can affect the shape of the uterus. The researchers want to see if placing a small balloon device (called a Foley catheter) inside the uterus after surgery can help stop this scar tissue, known as adhesions, from developing.

Women aged 18 and older who have a significant uterine septum (at least half the length of the uterus) and are planning to have surgery to remove it may be eligible to join the study. Participants will go through a shared decision-making process with their doctor and give informed consent before joining. The study is not yet recruiting, and certain women, such as those who have had previous septum surgery or other uterine surgeries, or those with existing scar tissue inside the uterus, will not be eligible. If you join, you can expect to have the usual surgery, and then the balloon device may be placed inside your uterus to help prevent new scar tissue from forming. This trial aims to find better ways to improve healing after this type of surgery.

Gender

FEMALE

Eligibility criteria

  • 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

About Weill Medical College Of Cornell University

Weill Medical College of Cornell University is a leading academic institution dedicated to advancing medical research and education. As a prominent sponsor of clinical trials, it focuses on innovative healthcare solutions and the development of new therapies across various medical disciplines. The institution is committed to fostering collaborative research efforts that enhance patient care and improve health outcomes. With a robust infrastructure and a team of experienced researchers and clinicians, Weill Cornell aims to translate scientific discoveries into practical applications, ensuring a strong emphasis on ethical standards and regulatory compliance throughout the clinical trial process.

Locations

New York, New York, United States

Little Rock, Arkansas, United States

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Glenn Schattman, MD

Principal Investigator

Weill Medical College of Cornell University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported