Intrauterine Stent Placement Following Hysteroscopic Septum Resection

NCT07032506 | Not Yet Recruiting

• 1 other identifier: 24-04027291
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The rate of intrauterine adhesion formation following hysteroscopic septoplasty

  12 weeks

Secondary Outcomes (6)

• Number of participants with Intraoperative complications

  12 weeks

• Number of participants with postoperative complications

  12 weeks

• Number of subjects completing postop intervention-hormone use

  12 weeks

• Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit

  12 weeks

• Long Term Reproductive Outcome

  3 years

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

No placement of an inflated intrauterine pediatric foley catheter

Procedure: No Catheter placement; Drug: Hormonal Therapy Agent

Interventions

No Catheter placement PROCEDURE

No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

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

Hormonal Therapy Agent DRUG

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)

Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter; Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter

Oral antibiotics DRUG

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

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

Intraoperative placement of an inflated intrauterine pediatric foley catheter PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (3)

Arkansas Fertility & Gynecology

Little Rock, Arkansas, 72205-0000, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

University Hospitals

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Gynatresia; Uterine Anomalies; Septate Uterus

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Duplication Anomalies; Uterine Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Glenn Schattman, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodriq Stubbs, NP, MSN

CONTACT

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

Sarah Cambria

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)