Safety and Performance Evaluation for the AEGEA Global Endometrial (GEA) System in Women Scheduled to Undergo a Hysterectomy.

Conditions: excessive menstrual loss
menorrhagia
10029903

Registration Number: NL-OMON35770

Lead Sponsor: AEGEA Medical Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

1. Age 30-50 years
2. Patient consented to undergo hysterectomy prior to being approached to this study
3. Functional endometrium presently visible on ultrasound within 30 days
4. Able to provide written informed consent
5. Fundal length <= 12 cm
6. Normal PAP results within 6 months prior to enrollment
7. Normal endobiopsy results within 30 days prior to enrollment
8. Negative pregnancy test within 1 day prior to procedure

Exclusion Criteria

1. Post-menopausal
2. Planned hysterectomy involving uterine morcellation
3. Active pelvic inflammatory disease
4. Gynaecological malignancy within the past 5 years
5. Known/suspected abdominal/ pelvic cancer
6. Septate uterus
7. Abnormal PAP results unless appropriately evaluated
8. Submucosal myomas or polyps > 1cm in diameter
9. Patients with intramural or subserosal fibroids that either distort the uterine cavity or are > 4 cm in diameter
10. Cervical length < 2 cm
11. Previous endometrial ablation procedure or classical c-section or transmural myomectomy
12. Patients with anatomy that is identified by the PI to be at risk for inadequate cervical seal with the Vapor Probe balloon
13. Any general health condition, which, in the opinion of the PI, could represent an increased risk for the potential patient.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is safety. This will be determined by the absence of<br /><br>adverse events associated with the AEGEA-VAPOR treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The performance of the VAPOR system will be measured by:<br /><br><br /><br>1. If satisfactory placement of the VAPOR-probe is achieved<br /><br>2. If placement of the VAPOR probe is maintained throughout vapor delivery<br /><br>3. If the target intra-uterine pressure can be achieved<br /><br>4. Absence of clinically significant thermal injury in the cervical canal or<br /><br>vagina based on inspection, histopathology and adverse event reporting.<br /><br>5. Generator panel displays vapor delivery elapsed time, VAPOR probe pressure<br /><br>and temperature<br /><br>6. Intrauterine pressure does not exceed maximum vapor shut off limit (50 mm Hg)<br /><br>7. Thermocouples (serosa and cervical) do not exceed 44 *C<br /><br>8. Generator alarms operate as intended</p><br>