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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35770

Enrollment

Registered

2011-10-27

Start date

2011-07-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

excessive menstrual loss menorrhagia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is safety. This will be determined by the absence of adverse events associated with the AEGEA-VAPOR treatment	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results