Infertility of Tubal OriginNCT05775913
Clinical Evaluation of a Tubal Selective Delivery System
A study testing Tubal Selective Delivery System (TSDS) in people with Infertility of Tubal Origin, run by Oregon Health and Science University.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility of Tubal Origin
- What is being tested?
- Tubal Selective Delivery System (TSDS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2027to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection
- History of involuntary female infertility
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- History of gynecologic surgery involving the uterus, fallopian tubes, or ovaries (except single cesarean section)
- History of prior permanent contraception procedure (any technique, abdominal laparoscopic, or hysteroscopic)
- Pelvic exam findings considered clinically-significant by the investigator such as uterine fibroids, pelvic tenderness, or prolapse
- Inability to tolerate placement of a tenaculum and/or uterine sound during screening exam
- Any congenital or acquired uterine anomaly that may complicate study drug placement, such as:
- Submucosal uterine leiomyoma
- Asherman's syndromes
- Pedunculated polyps
- Bicornuate uterus
- Didelphys or uterine septa
- Any distortions of the uterine cavity (e.g., fibroids), that, in the opinion of the investigator, are likely to cause issues during insertion, use or removal of the TSDS.
- Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior trachelectomy or extensive conization that, in the opinion of the investigator would prevent cervical dilation and device placement
- Untreated or unresolved acute cervicitis or vaginitis
- Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS
- Screening transabdominal or transvaginal ultrasound findings with poor imaging quality, or anatomic abnormalities considered clinically important or likely to interfere with assessment of the test device, as assessed by the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of an Intrauterine Selective Balloon Catheter System for Transcervical Delivery of Selected Agents to the Fallopian Tube
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.
Read the 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
- Infertility of Tubal Origin
- Being tested
- Tubal Selective Delivery System (TSDS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubal Selective Delivery System (TSDS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Tubal Selective Delivery System | Experimental | The same intervention will be used for all study subjects. Receives: Device: Tubal Selective Delivery System (TSDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of catheter during insertion of device
Clinician impression of catheter performance during insertion of device. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as:
Excellent: Clinician can place the insertion tube transcervically without dilation, and advance the obturator to expand the device without the use of imaging guidance.
Acceptable: Cervical dilation required, but easy to advance the obturator to expand the device without the use of imaging guidance
Fail: Unable to place the insertion tube
Measured: Immediately post-procedure within 30 minutes
Expansion of arms and dual catheters
Expansion of arms and dual catheters in the two uterine cornua. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as:
Excellent: Arms extend into bilateral cornua following transcervical insertion after initial expansion. Ultrasound confirms extension but is not needed
Acceptable: Ultrasound is required to position arms, but expansion is successful after one or two attempts.
Fail: Clinician is unable to position arms into cornua.
Measured: During procedure immediately following attempt to position device
Inflation of dual balloons
Inflation of the dual balloons. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as:
Excellent: Inflation of the dual balloons on first attempt by the clinician with no leakage or bad connections. This is confirmed by ultrasound.
Acceptable: Inflation requires more than one attempt but is ultimately successful.
Fail: Clinician is unable to inflate balloons due to high pressure or subject pain.
Measured: During procedure immediate following attempt to inflate balloons
Delivery of saline
Delivery of saline. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as:
Excellent: Successful administration of saline at low pressure (confirmed by ultrasound) with no leakage or bad connections.
Acceptable: Some leakage of saline, but clinician is able to observe flow in tubes.
Fail: Clinician unable to administer saline due to high pressure/pain, leakage or bad connections.
Measured: During procedure immediate following attempt to administer saline
Delivery of ExEm foam
Delivery of ExEm foam. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as:
Excellent: Delivery of foam at low pressure with confirmation of tubal patency via ultrasound and with no leakage or bad connections.
Acceptable: Some leakage of ExEm in uterine cavity, but clinician is able to observe flow in tubes.
Fail: Clinician unable to administer ExEm due to high pressure/pain, leakage or bad connections.
Measured: During procedure immediate following attempt to administer ExEm foam
Clinician impression of device removal
Clinician impression of device removal. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as:
Excellent: Clinician can deflate balloons, collapse frame, and withdraw insertion tube without difficulty at the end of procedure without the use of imaging guidance.
Measured: During procedure immediate following attempt remove device
Secondary outcomes (2)
Tolerability and ease of use - Provider experience evaluation
The clinician placing the device will evaluate ease of use using a series of 100 mm visual analog scale (anchors: 0 extremely easy; 100 extremely difficult/impossible) to evaluate these questions: Was the device easy to insert transcervically? Was inflation of the balloons easy? Was deliver of saline easy? Was deliver of ExEm foam easy? Was removal easy?
Measured: Immediately Post-procedure (within 30 minutes)
Tolerability and ease of use - Patient experience evaluation
Participants will indicate maximum level of pain experienced during study procedures using 100 mm visual analogue scale (VAS) at various time points. We will compare pain with placement, treatment, and removal to several baseline assessments. VAS scales: Baseline expectation of pain, baseline pain immediately following speculum placement, baseline pain immediately prior to placement, pain associated with insertion, pain associated with balloon inflation, pain associated with administration of saline, pain associated with administration of ExEm foam, pain associated with complete device removal, pain 15 minutes after completion of procedure, overall satisfaction with procedure, willingness to recommend procedure to a friend.
Measured: Pre-procedure, during procedure, immediately post-procedure, 15 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study startDec 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility of Tubal OriginStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Jensen, Oregon Health and Science University
- Investigators
- Jeffrey Jensen, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775913
- Sponsor's protocol ID
- OHSU IRB 24448
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Intrauterine Selective Balloon Catheter System for Transcervical Delivery of Selected Agents to the Fallopian Tube
- ClinicalTrials.gov ID
- NCT05775913
- Acronym / sponsor ID
- OHSU IRB 24448
- Conditions
- Infertility of Tubal Origin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Dec 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tubal Selective Delivery System | Experimental | Device: Tubal Selective Delivery System (TSDS)The same intervention will be used for all study subjects. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- 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 clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Tubal Selective Delivery System |
Primary outcome
Clinical performance of catheter during insertion of device
Time frame: Immediately post-procedure within 30 minutes
Clinician impression of catheter performance during insertion of device. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as: Excellent: Clinician can place the insertion tube transcervically without dilation, and advance the obturator to expand the device without the use of imaging guidance. Acceptable: Cervical dilation required, but easy to advance the obturator to expand the device without the use of imaging guidance Fail: Unable to place the insertion tube
Expansion of arms and dual catheters
Time frame: During procedure immediately following attempt to position device
Expansion of arms and dual catheters in the two uterine cornua. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as: Excellent: Arms extend into bilateral cornua following transcervical insertion after initial expansion. Ultrasound confirms extension but is not needed Acceptable: Ultrasound is required to position arms, but expansion is successful after one or two attempts. Fail: Clinician is unable to position arms into cornua.
Inflation of dual balloons
Time frame: During procedure immediate following attempt to inflate balloons
Inflation of the dual balloons. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as: Excellent: Inflation of the dual balloons on first attempt by the clinician with no leakage or bad connections. This is confirmed by ultrasound. Acceptable: Inflation requires more than one attempt but is ultimately successful. Fail: Clinician is unable to inflate balloons due to high pressure or subject pain.
Delivery of saline
Time frame: During procedure immediate following attempt to administer saline
Delivery of saline. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as: Excellent: Successful administration of saline at low pressure (confirmed by ultrasound) with no leakage or bad connections. Acceptable: Some leakage of saline, but clinician is able to observe flow in tubes. Fail: Clinician unable to administer saline due to high pressure/pain, leakage or bad connections.
Delivery of ExEm foam
Time frame: During procedure immediate following attempt to administer ExEm foam
Delivery of ExEm foam. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as: Excellent: Delivery of foam at low pressure with confirmation of tubal patency via ultrasound and with no leakage or bad connections. Acceptable: Some leakage of ExEm in uterine cavity, but clinician is able to observe flow in tubes. Fail: Clinician unable to administer ExEm due to high pressure/pain, leakage or bad connections.
Clinician impression of device removal
Time frame: During procedure immediate following attempt remove device
Clinician impression of device removal. Performance is categorized as one of three levels: excellent, acceptable, or fail. The number of participants in each category will be reported, with categories defined as: Excellent: Clinician can deflate balloons, collapse frame, and withdraw insertion tube without difficulty at the end of procedure without the use of imaging guidance.
2 secondary outcomes
Tolerability and ease of use - Provider experience evaluation
Time frame: Immediately Post-procedure (within 30 minutes)
Tolerability and ease of use - Patient experience evaluation
Time frame: Pre-procedure, during procedure, immediately post-procedure, 15 minutes post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Recruiting
In Vitro Maturation of Human Eggs
Healthy, PCOS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Jensen, MD principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
A study testing Tubal Selective Delivery System (TSDS) in people with Infertility of Tubal Origin, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Women's Health Research Unit Department of Ob/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of catheter during insertion of device (time frame: Immediately post-procedure within 30 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.