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)

Phase 3

Completed

Conditions: adhesions within endometrial cavity
cavitary healing
10046828

Registration Number: NL-OMON43089

Lead Sponsor: AEGEA Medical Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 17

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety Endpoints: The safety endpoints will be an assessment of:<br /><br>* Diagnostic hysteroscopy procedure-related serious adverse events<br /><br>* The overall rate and severity of all reported adverse events<br /><br><br /><br>Primary Observational<br /><br>Endpoint: The ability to access the endometrial cavity and perform a diagnostic<br /><br>hysteroscopic exam greater than 24 months following endometrial ablation with<br /><br>the AEGEA Vapor System. The extent of cavity access will be determined by how<br /><br>far the hysteroscope can be advanced into the uterine cavity. The distance of<br /><br>hysteroscope insertion into the cavity will be categorized as lower, middle or<br /><br>fundal cavity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other Observational<br /><br>Endpoints:<br /><br>* The ability to visualize the uterine cornua<br /><br>* Presence, location and extent of adhesions within the endometrial cavity<br /><br>* Presence, location and extent of residual endometrial tissue<br /><br>* Presence and location of novel observations regarding cavitary healing</p><br>