Clinical Evaluation of a Tubal Selective Delivery System

Infertility of Tubal Origin Clinical Trial

Official title: Development of an Intrauterine Selective Balloon Catheter System for Transcervical Delivery of Selected Agents to the Fallopian Tube

Status Not yet recruiting

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. ;

Related Conditions & MeSH terms

• Infertility
• Infertility of Tubal Origin

• 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: January 2026
• Completion date: December 2026