Clinical Evaluation of a Tubal Selective Delivery System
NCT05775913 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-07-31
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.
Conditions
- Infertility of Tubal Origin
Interventions
- 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.
Sponsors & Collaborators
-
Oregon Health and Science University
lead OTHER
Principal Investigators
-
Jeffrey Jensen, MD · Oregon Health and Science University
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-12-31
- Primary Completion
- 2027-12-31
- Completion
- 2028-03-31
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