Surgical Approach to Uterine Septum

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06315582
Status
Recruiting
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Conditions

  • Septum; Uterus
  • Surgical Complication
  • Treatment
  • Treatment Side Effects
  • Uterine Septum

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • Removal of uterine septum with hysteroscopic scissors without electrosurgery. — PROCEDURE
    Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue
  • Hysteroscopic septoplasty utilizing bipolar electrosurgery — PROCEDURE
    Hysteroscopic septoplasty utilizing bipolar electrosurgery

Study Details

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.

Key Dates

Start date
Mar 11, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Procedure-level variables: operative time hysteroscopic septoplasty [ Time Frame: During the intervention/procedure/surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Medicine Prentice Women's HospitalChicagoIllinois60611
Milad Madgy, MD
[email protected]

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Northwestern Medicine Prentice Women's Hospital· Chicago, IL

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