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Clinical Trial Summary

A single center study to evaluate the performance and optimize the design of a novel intrauterine catheter system intended as a nonsignificant risk medical device to aid in evaluating tubal patency as part of the initial diagnostic workup for infertility.


Clinical Trial Description

In this study, the investigators will perform transcervical placement of a novel tubal selective delivery catheter system in a controlled clinical setting, using ultrasound imaging to evaluate device performance in a short procedure that will not require sedation or general anesthesia (local anesthesia may be used). The investigator will confirm the position of the device, inflate the balloons, and administer a small volume (10 mL) of an FDA-approved contrast foam. The investigator will then remove the device at the end of the procedure. This study will evaluate performance of the device, ease of use, and patient experience. It will also evaluate the patient experience before, during, and after the procedure. This device is meant to be used to assess tubal patency as part of the initial diagnostic workup for infertility, and use of the device may reduce the need for HSG. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05775913
Study type Interventional
Source Oregon Health and Science University
Contact Women's Health Research Unit Department of Ob/Gyn
Phone 503-494-3666
Email whru@ohsu.edu
Status Not yet recruiting
Phase N/A
Start date December 2023
Completion date May 2024

See also
  Status Clinical Trial Phase
Completed NCT04077242 - Hysteroscopic Evaluation of Fallopian Tubal Patency N/A
Recruiting NCT03174873 - Tubal Factor in Unexplained Infertility N/A
Not yet recruiting NCT04945265 - Effects of Age and Infertility on Ovarian Granulosa Cell Function
Completed NCT05209542 - Hysterosalpingo-Foam Ultrasonography Combined With Power Doppler, Compared With Laparoscopy in Tubal Patency Assessment in Cases of Infertility N/A