Clinical Evaluation of a Tubal Selective Delivery System (NCT05775913) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Evaluation of a Tubal Selective Delivery System
12 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Literate in English
* Able to understand and sign an IRB-approved informed consent form
* Willing to complete a pre-procedure questionnaire
* Regular menstrual cycles (24- 38 days)
* Good general health
* Able and willing to comply with all study tests, procedures, and assessment tools
* Uterine sound size between 6 - 10 cm
* Agree to use a non-hormonal method of contraception or avoid vaginal intercourse during the catheter evaluation cycle
* In compliance with cervical cancer screening guidelines per the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without evidence of disease.
Alternatively, the subject must have had a colposcopy performed within the appropriate screen time frame, and prior to the study catheter insertion that showed no evidence of dysplasia requiring treatment or further diagnostic procedures or follow-up for at least 6 months
Exclusion Criteria:
* Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test
* Currently using hormonal contraception. Must have at least one natural cycle (two menses) prior to participation if recently discontinued hormonal contraception.
* Currently using an intrauterine device (IUD). Must discontinue at least 30 days prior to Visit 2
* Allergy or hypersensitive to radio-opaque contrast, ExEm foam, both doxycycline and azithromycin (allergy to one not exclusionary if can take the alternative), or lidocaine
* History or physical findings recognized as…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical performance of catheter during insertion of device
Timeframe: Immediately post-procedure within 30 minutes
2
Expansion of arms and dual catheters
Timeframe: During procedure immediately following attempt to position device
3
Inflation of dual balloons
Timeframe: During procedure immediate following attempt to inflate balloons
4
Delivery of saline
Timeframe: During procedure immediate following attempt to administer saline
5
Delivery of ExEm foam
Timeframe: During procedure immediate following attempt to administer ExEm foam
6
Clinician impression of device removal
Timeframe: During procedure immediate following attempt remove device