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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Clinical performance of catheter during insertion of device
Timeframe: Immediately post-procedure within 30 minutes
Expansion of arms and dual catheters
Timeframe: During procedure immediately following attempt to position device
Inflation of dual balloons
Timeframe: During procedure immediate following attempt to inflate balloons
Delivery of saline
Timeframe: During procedure immediate following attempt to administer saline
Delivery of ExEm foam
Timeframe: During procedure immediate following attempt to administer ExEm foam
Clinician impression of device removal
Timeframe: During procedure immediate following attempt remove device