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Search / Trial NCT04550429

Uterine Filling Pressure in Hysteroscopy

Launched by NORTHWESTERN UNIVERSITY · Sep 14, 2020

Trial Information

Current as of May 29, 2025

Completed

Keywords

ClinConnect Summary

An a priori sample size calculation was completed. To achieve 80% power and an alpha of .05, the study team needed a sample size of 68 total with 34 participants in each group.The study will be a double-blind randomized control trial. Patients will be recruited based on surgery type (hysteroscopy) and consented using a written consent by the research coordinator with sufficient time to ensure patient comprehension and allow for any questions. The consent process will happen in the pre-operative appointment. Participants will then be randomized to either the standard of care of 80mmHg or the...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Patients electing for operative or diagnostic hysteroscopy procedures for management of polyps and fibroids
  • Age equal to or greater than 18
  • Ability to understand and willingness to sign consent form. We will include non-English speaking patients in this study
  • Exclusion Criteria:
  • Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids
  • Patients under the age of 18

About Northwestern University

Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Magdy P Milad, MD, MM

Principal Investigator

Northwestern University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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