The purpose of this study is to demonstrate that the use of the Vapor System is safe and effective. It will be tested in patients who were already planned to undergo a hysterectomy and the device thus has no therapeutic purpose in this particular…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is safety. This will be determined by the absence of
adverse events associated with the AEGEA-VAPOR treatment
Secondary outcome
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
Background summary
Heavy menstrual bleeding are common problems in pre-menstrual women. Hormonal
therapy and hysterectomy are common treatments, of which especially the last
one is very invasive for the patient. It is associated with it considerable
risks. These days, endometrial ablation is becoming a more commonly used
treatment method. During the ablation of the endometrium, the lining of the
uterus is being removed and the uterus remains intact.
Global Endometrial Ablation Devices can be used to perform such endometrial
ablations. An example is the Aegea GEA Vapor system, the medical device which
is being tested in this study.
Study objective
The purpose of this study is to demonstrate that the use of the Vapor System is
safe and effective. It will be tested in patients who were already planned to
undergo a hysterectomy and the device thus has no therapeutic purpose in this
particular study. VAPOR-treatment prior to hysterectomy allows the performance
of the device under test while the risk for the patient are minimized. Also,
the degree of ablation of the endometrium will be evaluated in pathological
examination of tissue after the treatment. The results of this study will
determine whether the Vapor-system can be used for ablation in the future in
the assigned patient population.
Study design
This is a prospective, non-randomized, multi-center and open-label study
Study burden and risks
The risk for the subjects in this study are estimated to be low. In this study,
a peri-hysterectomy is being performed to assess the safety and efficacy of the
Vapor endometrial ablation system. By treating/testing the patient prior to
hysterectomy, the risk of damage to surrounding organs by the steam will be
minimized. Also, the temperature of the outer wall of the uterus will be
monitored to confirm that the procedure is safe for future application in the
intended patient population (future research). No incisions are made**.
The stresses on the subjects will also be low because the patients already on
the waiting list for a hysterectomy and no need to fill in questionnaires or
the like.
In conclusion, the burden and risks for these patients will be low. And
thorough investigation of the VAPOR device will inform us whether it is a safe
and effective device for future ablations.
2686 Middlefield Rd, Suite A
Redwood City, CA 94063
US
2686 Middlefield Rd, Suite A
Redwood City, CA 94063
US
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36727.072.11 |