The Post-Ablation Cavitary Evaluation (PACE) Clinical Trial;(A pilot, prospective, observational clinical trial to evaluate the uterine cavitary architecture of patients who have previously undergone endometrial ablation with the AEGEA Vapor System for treatment of heavy menstrual bleeding) - PACE

AEGEA Medical Inc0 个研究点目标入组 17 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•1. Able to understand and has voluntarily signed and dated the Ethics Committee (EC) approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure;
•2. Normal PAP or ASCUS PAP with negative HR HPV, within the past 5 years, or ASCUS HPV positive/low grade SIL who have been appropriately evaluated and managed;
•3. Able and willing to comply with all study tests and procedures.

•1. Is pregnant as determined by urine pregnancy test during screening on the day of the hysteroscopy procedure;
•2. Evidence of an active sexually transmitted infection (STI) as determined by study screening evaluation just prior to the planned hysteroscopy;
•3. Active infection of the genitals, vagina, cervix, uterus or urinary tract, at the time of the hysteroscopy procedure, as detected by study screening examination and patient symptoms;
•4. Suspected or confirmed gynecologic malignancy within the last five years as confirmed by histology;
•5. Any general health condition that, in the opinion of the Investigator, could represent an increased risk for the subject;
•6. Known allergy or intolerance to anesthesia.

发起方

AEGEA Medical Inc