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

Overview

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.

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.

Primary outcome measures

• Clinical performance of catheter during insertion of device [Time frame: Immediately post-procedure within 30 minutes]
• Expansion of arms and dual catheters [Time frame: During procedure immediately following attempt to position device]
• Inflation of dual balloons [Time frame: During procedure immediate following attempt to inflate balloons]
• Delivery of saline [Time frame: During procedure immediate following attempt to administer saline]
• Delivery of ExEm foam [Time frame: During procedure immediate following attempt to administer ExEm foam]
• Clinician impression of device removal [Time frame: During procedure immediate following attempt remove device]

Secondary outcome measures (2)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05775913 · OHSU IRB 24448

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗