Clinical Evaluation of a Tubal Selective Delivery System

Oregon Health & Science University (OHSU)

Status

Begins enrollment in 5 months

Conditions

Infertility of Tubal Origin

Treatments

Device: Tubal Selective Delivery System (TSDS)

Study type

Interventional

Funder types

Other

Identifiers

NCT05775913

OHSU IRB 24448

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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