To determine the feasibility of hysteroscopically accessing and visualizing the uterine cavity greater than 24 months following a completed endometrial ablation with the AEGEA Vapor System
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety Endpoints: The safety endpoints will be an assessment of:
* Diagnostic hysteroscopy procedure-related serious adverse events
* The overall rate and severity of all reported adverse events
Primary Observational
Endpoint: The ability to access the endometrial cavity and perform a diagnostic
hysteroscopic exam greater than 24 months following endometrial ablation with
the AEGEA Vapor System. The extent of cavity access will be determined by how
far the hysteroscope can be advanced into the uterine cavity. The distance of
hysteroscope insertion into the cavity will be categorized as lower, middle or
fundal cavity.
Secondary outcome
Other Observational
Endpoints:
* The ability to visualize the uterine cornua
* Presence, location and extent of adhesions within the endometrial cavity
* Presence, location and extent of residual endometrial tissue
* Presence and location of novel observations regarding cavitary healing
Background summary
This pilot clinical evaluation, conducted with the consent of subjects who
previously participated in the AEGEA Phase II Feasibility Clinical Trial, will
attempt to characterize the state of the endometrial cavity more than 24 months
following treatment with the AEGEA Vapor System.
Study objective
To determine the feasibility of hysteroscopically accessing and visualizing the
uterine cavity greater than 24 months following a completed endometrial
ablation with the AEGEA Vapor System
Study design
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
This study will be conducted at up to 3 centers in The Netherlands where the
AEGEA Phase II trial was previously completed. The hysteroscopy procedures
will be done in a private practice office or outpatient setting.
Up to 17 subjects who previously completed the AEGEA Phase II Feasibility
Clinical Trial (Protocol SE-2000), and were not withdrawn or lost-to-follow-up,
will be consented and screened.
Study Duration: An estimated 2 months for subject enrollment and completion of
the hysteroscopy procedures
Follow up: Subjects will exit the trial following the hysteroscopy. There are
no follow up visits
Study burden and risks
There are no risks with relation to an investigative Medical Device. The only
risks are that of a diagnostic hysteroscopy (not experimental). The possible
benefits for the patients outweigh the risks.
Middlefield Road, Suite A 2686
Redwood City, California 94063
US
Middlefield Road, Suite A 2686
Redwood City, California 94063
US
Listed location countries
Age
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.
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 | NL57261.072.16 |