Intrauterine Stent for Uterine Abnormalities

Not yet recruiting at 2 trial locations

Overseen By Sarah Cambria

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Prior septum resection, Transmural surgery, Adhesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to prevent scar tissue inside the uterus after surgery to repair a uterine septum (a wall of tissue that divides the uterus). Researchers are testing whether placing a small balloon inside the uterus after surgery can prevent scar tissue formation. Participants will either have the balloon placed or not after their surgery. Women scheduled for a specific type of uterine surgery to remove a septum, with at least half of their uterus affected, might be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the intrauterine stent placement is safe for preventing uterine abnormalities?

Research has shown that intrauterine stents, like the one being studied, are generally safe. For instance, one study found that a similar device, the Jada device, successfully controlled bleeding in 94% of cases, indicating it is well-tolerated. Another study examined an intrauterine balloon stent and found it to be safe, although some participants experienced infections. About one-third of the balloon stent group had positive microorganism cultures, meaning some bacteria were found, but they were not necessarily harmful.

These findings suggest that while some risks, such as possible infections, exist, intrauterine stents are generally considered safe and effective for many patients. Always discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intrauterine stent technique for uterine abnormalities because it offers a novel approach compared to standard treatments like hormonal therapy and surgical interventions. Unlike existing options, this method involves the placement of an inflated intrauterine pediatric Foley catheter, which stays in place for 7-10 days post-surgery. This mechanical approach may provide physical support and potentially improve surgical outcomes without relying solely on hormone-based therapies. By providing a new delivery method, this technique could offer a quicker and more localized solution, reducing the reliance on systemic treatments.

What evidence suggests that this trial's treatments could be effective for preventing internal scar tissue after septum removal?

Research has shown that using an intrauterine stent, similar to a small tube, can help prevent internal scar tissue after surgery. In this trial, one group of participants will receive an intraoperative placement of an inflated intrauterine pediatric Foley catheter, a type of stent, which will remain in place for 7-10 days post-surgery. Studies indicate that placing a stent can effectively reduce the risk of scar tissue recurrence and help restore the uterus's shape. One study found that the chances of ongoing pregnancy were similar between those using a balloon and those using an intrauterine device (IUD), suggesting the balloon is as effective as other methods. Another study found that using a stent is effective and easy for treating mild-to-moderate internal scar tissue. Overall, these findings suggest that intrauterine stents may help reduce scar tissue after surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Glenn Schattman, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals with uterine conditions like scarring (synechiae), a septate uterus, other abnormalities, or Asherman's Syndrome. Specific inclusion and exclusion criteria are not provided but would typically detail the precise characteristics required for participation.

Inclusion Criteria

My ultrasound shows a uterine septum that takes up at least half of my uterus.

I have chosen to have a procedure to correct my uterine septum after discussing it with my doctor.

I am 18 years old or older.

Exclusion Criteria

Unwilling or unable to provide informed consent

I have had surgery to remove a uterine septum.

My condition cannot be treated with just one surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Immediate Post-operative Care

Participants undergo hysteroscopic septum resection and are randomized to receive either an intrauterine foley catheter balloon with hormonal supplementation or hormonal supplementation only

7-10 days

1 visit (in-person)

Post-operative Monitoring

Participants undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation

Up to 12 weeks

1 visit (in-person)

Follow-up

Participants are monitored for long-term reproductive outcomes, including pregnancy achievement

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Hormonal Therapy Agent
• Intrauterine Stent Placement

Trial Overview The study is examining whether using an inflated intrauterine pediatric foley catheter after hysteroscopic septum resection helps prevent internal scar tissue. It compares this method to no catheter placement post-surgery, alongside hormonal therapy agents and oral antibiotics.

How Is the Trial Designed?

Group I: Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter Experimental Treatment 3 Interventions

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

Group II: Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter Active Control 2 Interventions

No placement of an inflated intrauterine pediatric foley catheter

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7049051/

A preliminary study on a patented intrauterine stent in the ... This study aimed to assess the safety and effectiveness of a patented intrauterine stent as a barrier in the treatment of recurrent IUAs with poor prognosis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11036709/

Short-term reproductive outcomes analysis and prediction ... A modified uterine stent placement under hysteroscopy was an effective approach for mild-to-moderate intrauterine adhesions, which is easy to operate and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537021004818

Articles Reproductive outcomes and ... The ongoing pregnancy rates (balloon 56·4% versus IUD 57·1%) and miscarriage rates (balloon 10·3% versus IUD 22·9%) were not significantly different between the ...

4. rbej.biomedcentral.com rbej.biomedcentral.com/articles/10.1186/s12958-024-01222-w

Comparing the efficacy and pregnancy outcome of intrauterine ... Inserting a balloon or placing an IUD for one or two months can effectively lower the risk of adhesion recurrence and restore the shape of the uterine cavity.

5. academic.oup.com academic.oup.com/humupd/article/31/6/588/8248883

epidemiology, clinical burden, and prevention of intrauterine ... This systematic review comprehensively analyzes IUA formation following uterine surgical procedures and adjuvant therapy effectiveness. Even ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01167296

Safety of Leaving Cook Balloon Uterine Stent in Uterus for ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. ajog.org ajog.org/article/S0002-9378(23)00550-1/fulltext

Intrauterine devices in the management of postpartum ... The Jada device, which is is FDA-cleared and commercially available in the US, found successful bleeding control in 94% of cases in an initial single-arm trial, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211516300185

a cohort study comparing three different adjuvant therapies The intrauterine adhesion rates among the four groups at one month were 22.0%, 28.81, 26.7% and 24.1% (p > 0.05); and at the third month were 0%, 1.7%, 1.3% and ...

9. researchgate.net researchgate.net/publication/270290490_Safety_and_acceptability_of_intrauterine_balloon_stent_used_in_uterine_after_hysteroscopic_adhesiolysis_to_prevent_adhesion_reformation

Safety and acceptability of intrauterine balloon stent used ... Positive microorganism cultures were seen in 17 patients (33.3%) in balloon group versus 8 (28.6%) in intrauterine contraceptive device group.