Trials / Not Yet Recruiting
Not Yet RecruitingNCT05775913
Clinical Evaluation of a Tubal Selective Delivery System
Development of an Intrauterine Selective Balloon Catheter System for Transcervical Delivery of Selected Agents to the Fallopian Tube
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tubal Selective Delivery System (TSDS) | A novel tubal selective delivery catheter system for selective delivery of administered agents to the fallopian tubes without entry of any portion of the catheter into the tubes. |
Timeline
- Start date
- 2026-12-01
- Primary completion
- 2027-12-01
- Completion
- 2028-03-01
- First posted
- 2023-03-20
- Last updated
- 2025-07-31
Source: ClinicalTrials.gov record NCT05775913. Inclusion in this directory is not an endorsement.