To Evaluate the Safety and Effectiveness of the Essure® ESS505 Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception (*Study*)
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Women ages range 21 to 44 years desiring permanent contraception
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint:
- Following successful device placement (as confirmed via transvaginal
ultrasound (*TVU*) confirmation test) performed at initial placement (day 0),
assess occurrence of confirmed pregnancy at three months among subjects relying
solely on ESS505 for contraception.
Secondary outcome
Secondary Endpoints:
- Following successful device placement as confirmed via a TVU, assess
occurrence of confirmed pregnancies at 12 months after device placement among
subjects relying solely on ESS505 for contraception.
- Assess severity and frequency of reported adverse events related to the
device placement procedure.
- Assess severity and frequency of adverse events reported among subjects in
whom one or more ESS505 inserts are placed.
Background summary
Evaluate the safety and long*term (approximately one year) effectiveness of the
Essure System for Permanent Birth Control ESS505 device in
preventing pregnancy.
Study objective
To Evaluate the Safety and Effectiveness of the Essure® ESS505 Device to
Prevent Pregnancy in Women Who Are Seeking Permanent Contraception (*Study*)
Study design
This study is a prospective, multicentre, non*randomised, non*control,
international study (*Study*).
- Female subjects are eligible to participate in the Study if she is seeking
permanent contraception.
- Subjects must undergo informed consent process and consent in writing to
participate in the Study.
- Subjects will be screened to determine enrolment eligibility as defined by
Study Inclusion and Exclusion criteria.
- Pre*procedural medical history and physical examinations will be completed in
accordance with regional standard of care with the inclusion of required
pregancy testing.
- Subjects will undergo device placement procedure.
- Subjects will undergo TVU <=3 hour (not to exceed 3 hrs post placement)
confirmation test post a successful placement procedure to confirm satisfactory
insert location.
- Subjects follow*up care and discharge will be in accordance with regional
standard of care.
- Subjects are requested to complete a three*month office visit (±14 business
days) at which a pregnancy test will be administered. Subjects will be
interviewed to determine subject*s clinical status i.e., incidence of
pregnancy, occurence of extirpative surgeries and/or placement/device*related
adverse events.
- Subjects are requested to complete a telephone interview at twelve months
(±14 business days) post insert placement procedure.
- Subjects will be interviewed to determine clinical status i.e., incidence of
pregnancy, occurrence of extirpative surgeries and/or placement/device*related
adverse events.
- Subjects Study participation ends at the completion of the 12*month telephone
interview or early withdrawal from the study.
Intervention
Subjects meeting study eligibility requirements will be clinically assessed and
confirmed as appropriate for ESS505 placement.
ESS505 insert location will be evaluated and validated via TVU confirmation
test performed <=3 hours post successful insert placement. If the TVU
confirmation test is unsatisfactory, the insert placement and tubal occlusion
will be evaluated by hysterosalpingogram (HSG).
Study burden and risks
The investigational device, ESS505, is developed to obviate the necessity for
adjunct contraception, which is required by labelling with the ESS305 device,
during the 3-month tissue in-growth period following device implant potentially
effecting increased patient safety and health-care cost savings. Right after
the bilateral implant (as confirmed by transvaginal ultrasound) of the ESS 505
device, the study subject can be confident that these protect against
pregnancy, even if the closure of the fallopian tubes by tissue ingrowth will
only fully occur three months after placement.
McCarthy Boulevard 1011
Milpitas CA 95035
US
McCarthy Boulevard 1011
Milpitas CA 95035
US
Listed location countries
Age
Inclusion criteria
1. Females with age range 21 to 44 years;
2. Subjects seeking permanent contraception;
3. Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds);
4. Subjects willing to accept the risk of pregnancy occurring whilst relying solely on the ESS505 for contraception;
5. Subjects for whom medical physical history indicate bilateral viable and patent fallopian tubes;
6. Subjects are able to comply with the protocol required follow-up visits (e.g., 3-month clinic visit, and the 12-month telephone interview);
7. Subjects provide written informed consent prior to enrolment;
8. Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding their experience wearing the device;
9. Subjects who agree that anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies;
10. Subjects have no contraindications for use as described in the ESS505 Instructions for Use (*IFU*), i.e. women with bilateral proximal tubal occlusion, women who have undergone fallopian tube sterilization, women with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia, women who are post-menopausal, women with pelvic inflammatory disease, women who are pregnant or may become pregnant, women wih gynecologic malignancy, women with a general systemic disease or condition that could represent a risk, women who deliveres or terminated a pregnancy less than 6 weeks before Essure insert placement, women with a known allergy to contrast media, women with any general health condition that may represent, in the opinion of the physician, an increased potential risk associated with device use.
Exclusion criteria
1. Subjects with known proximal tubal occlusion in either fallopian tube;
2. Subjects who has undergone fallopian tube sterilisation procedure;
3. Subjects diagnosed with unicornuate uterus;
4. Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assess;
5. Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure. ;6. Subjects suspected of being or confirmed pregnant;
7. Subjects post-partum or undergone pregnancy termination <=6 weeks of scheduled ESS505 placement;
8. Subjects diagnosed with upper or lower pelvic infection;
9. Subjects for whom there are one or more contraindications for use as described in the ESS505 IFU;
10. Subjects with positive pre-procedure pregnancy test.
Design
Recruitment
Medical products/devices used
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 | NL41877.100.12 |