Clinical Evaluation of a Tubal Selective Delivery System

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

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.

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.

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.

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?

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.