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Balloon stent after uterine surgery may reduce scarring

NCT ID NCT07032506

Disease control Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether placing a small balloon in the uterus for 7-10 days after septum removal surgery can prevent internal scar tissue (adhesions). 320 women will be randomly assigned to receive the balloon plus hormones or hormones alone. The main goal is to see if the balloon lowers the rate of adhesion formation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intrauterine pediatric foley catheter balloon
What this could lead to
If it works, this could point toward a simple way to reduce scar tissue after uterine surgery, potentially improving fertility outcomes.
What could go wrong
This is a relatively small, early-stage trial. The balloon may cause discomfort or infection, and it is not yet clear if it will actually prevent adhesions better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gynatresia septate uterus uterine anomalies Asherman syndrome prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intrauterine adhesion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arkansas Fertility & Gynecology

    NOT_YET_RECRUITING

    Little Rock, Arkansas, 72205-0000, United States

  • University Hospitals

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

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