Recruiting

Foley Catheter

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07032506

Conditions

Intrauterine Adhesion

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraoperative placement of an inflated intrauterine pediatric foley catheter

No Catheter placement

Hormonal Therapy Agent

Oral antibiotics

Study Details

Brief summary:

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.

Conditions

Intrauterine Adhesion

Study ID

NCT07032506

Start date

May 14, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter

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

active comparator: Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter

No placement of an inflated intrauterine pediatric foley catheter

Interventions

Intraoperative placement of an inflated intrauterine pediatric foley catheter

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

No Catheter placement

No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

Hormonal Therapy Agent

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)

Oral antibiotics

100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place

Primary outcome measure

  • The rate of intrauterine adhesion formation following hysteroscopic septoplasty [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Rodriq Stubbs, NP, MSN

646-962-3276res2011@med.cornell.edu

Sarah Cambria

646-962-2961sac7011@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Rodriq Stubbs, NP

res2011@med.conrell.edu

Principal Investigator:

Glenn Schattman, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • intrauterine foley balloon catheter stent
  • uterine malformations
  • uterine septums
  • hysteroscopic septoplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-12.