NL-OMON35770Not yet recruitingNot Applicable
Safety and Performance Evaluation for the AEGEA Global Endometrial (GEA) System in Women Scheduled to Undergo a Hysterectomy. - VAPOR
AEGEA Medical Inc0 sites45 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
Investigators
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