Clinical trial NCT05775913: Clinical Evaluation of a Tubal Selective Delivery System
Official title: Development of an Intrauterine Selective Balloon Catheter System for Transcervical Delivery of Selected Agents to the Fallopian Tube
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility of Tubal Origin
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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 clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection
* History of involuntary female infertility
* 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

Primary outcomes:
measure: Clinical performance of catheter during insertion of device
timeFrame: Immediately post-procedure within 30 minutes
measure: Expansion of arms and dual catheters
timeFrame: During procedure immediately following attempt to position device
measure: Inflation of dual balloons
timeFrame: During procedure immediate following attempt to inflate balloons
measure: Delivery of saline
timeFrame: During procedure immediate following attempt to administer saline
measure: Delivery of ExEm foam
timeFrame: During procedure immediate following attempt to administer ExEm foam
measure: Clinician impression of device removal
timeFrame: During procedure immediate following attempt remove device
Secondary outcomes:
measure: Tolerability and ease of use - Provider experience evaluation
timeFrame: Immediately Post-procedure (within 30 minutes)
measure: Tolerability and ease of use - Patient experience evaluation
timeFrame: Pre-procedure, during procedure, immediately post-procedure, 15 minutes post-procedure
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Jeffrey Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References: