A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Fertility & Gynecology
NOT_YET_RECRUITING
Little Rock
New York
Weill Cornell Medicine
RECRUITING
New York
Ohio
University Hospitals
NOT_YET_RECRUITING
Cleveland
Contact Information
Primary
Rodriq Stubbs, NP, MSN
res2011@med.cornell.edu
646-962-3276
Backup
Sarah Cambria
sac7011@med.cornell.edu
646-962-2961
Time Frame
Start Date: 2026-05-14
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 320
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University