An interventional study of Intraoperative placement of an inflated intrauterine pediatric foley catheter and No Catheter placement in Intrauterine Adhesion, sponsored by Weill Medical College of Cornell University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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.
This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.
Patients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:
Surgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation within the first two menstrual cycles following the intervention, to be performed no later than 12 weeks following surgery.
99 studies on the registry are indexed under Gynatresia; 23 are open to participants now.
This study's planned enrollment of 320 is above the median of 100 across 87 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.
Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter · Drug: Hormonal Therapy Agent · Drug: Oral antibiotics
No placement of an inflated intrauterine pediatric foley catheter
Procedure: No Catheter placement · Drug: Hormonal Therapy Agent
Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.
No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon
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)
100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place
The rate of intrauterine adhesion formation following hysteroscopic septoplasty
Time frame: 12 weeks
Number of participants with Intraoperative complications
Time frame: 12 weeks
Number of participants with postoperative complications
Time frame: 12 weeks
Number of subjects completing postop intervention-hormone use
Time frame: 12 weeks
Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit
Time frame: 12 weeks
Long Term Reproductive Outcome
Number of subjects achieving pregnancy
Time frame: 3 years
Surgeon assessment of intervention modality
Surgeon assessment of whether intrauterine adhesions were prevented
Time frame: 12 weeks
Plan to share: No
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Weill Medical College of Cornell University →