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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
12
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.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: During procedure immediate following attempt remove device
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?
Time frame: 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.
Time frame: Pre-procedure, during procedure, immediately post-procedure, 15 minutes post-procedure