Recruiting

Surgical Approach

Sponsor:

Northwestern University

Code:

NCT06315582

Conditions

Uterine Septum

Surgical Complication

Septum; Uterus

Treatment Side Effects

Treatment

Eligibility Criteria

Sex: Female

Age: 22 - 44

Healthy Volunteers: Accepted

Interventions

Removal of uterine septum with hysteroscopic scissors without electrosurgery.

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Study Details

Brief summary:

The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.

Conditions

Uterine Septum

Surgical Complication

Septum; Uterus

Treatment Side Effects

Treatment

Study ID

NCT06315582

Start date

Mar 11, 2024

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 44

Healthy Volunteers: Accepted

Inclusion criteria

  • Have a confirmed septum (>1.0 cm) confirmed with 3D imaging and/or MRI
  • 20-44 years old

Exclusion criteria

  • Known tubal disease
  • Bleeding diastasis
  • No blood thinners
  • No concurrent laparoscopy scheduled
  • Patient with confirmed fibroids over >1 cm FIGO (International Federation of Gynecology and Obstetrics) type 1

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Study Intervention A (control group)

Hysteroscopic septoplasty utilizing bipolar electrosurgery

experimental: Study Intervention B (study group)

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Interventions

Removal of uterine septum with hysteroscopic scissors without electrosurgery.

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Primary outcome measure

  • Procedure-level variables: operative time hysteroscopic septoplasty [ Time Frame: During the intervention/procedure/surgery ]
  • Procedure-level variables: Surgical Cost [ Time Frame: During the surgery ]
  • Procedure-level variables: Fluid deficit [ Time Frame: During the surgery ]
  • Resolution of uterine septum [ Time Frame: Assess at 4 weeks post-op hysteroscopy ]

Central Contacts and Locations

Central contacts

Sarah L Rodriguez, MD

7863011284sarah.rodriguez@nm.org

Milad Madgy, MD

mmilad@nm.org

Locations

Northwestern Medicine Prentice Women's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Milad Madgy, MD

mmilad@nm.org

More Information

Sponsor

Northwestern University

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-06-01.