Evaluate the safety and effectiveness of the Essure System for Permanent Birth Control (Model ESS505) in preventing pregnancy
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
• Rate of confirmed pregnancies at 1 year among subjects told to rely
on ESS505 for contraception.
• Reliance rate: number of subjects told to rely on ESS505 after the
Essure confirmation test divided by the number of subjects who had insert
placement attempted.
Secondary outcome
• Occurrence of confirmed pregnancies at 10 years among subjects told to rely
on ESS505 for contraception.
• Safety of the ESS505 placement procedure defined as number of subjects who
experience an adverse event (AE) assessed as related to the
ESS505 placement procedure divided by the number of subjects in who at least 1
ESS505 was introduced into the fallopian tube.
• Safety of subsequent wearing of the insert defined as number of subjects who
experience an AE assessed as related to ESS505 wearing divided by the number of
subjects in whom the presence of an AE could be assessed.
Background summary
The Essure Permanent Birth Control System originally received Conformitè
Europèenne (CE) Mark approval in February 2001 and United States (US) Food and
Drug Administration (FDA) approval in November 2002. Currently, the Essure
procedure is a clinically and commercially established hysteroscopic
sterilization procedure. The Essure procedure is indicated for women who desire
permanent birth control (female sterilization) by bilateral occlusion of the
fallopian tubes.
The Essure procedure is conducted by using a transvaginal hysteroscopic
approach. One small, flexible Essure insert is placed in the proximal portion
of each fallopian tube. Upon release, the insert expands to conform to the
fallopian tube, acutely anchoring itself until the insert elicits tissue
in-growth. Prior clinical data demonstrate that total fallopian tube (tubal)
occlusion occurs within three months of placement, resulting in permanent
contraception.
The Sponsor has completed a design modification of the current commercially
available Essure ESS305 into investigational device Model ESS505 (manufactured
by Bayer HealthCare LLC). The ESS505*s primary design modification is the
addition of a hydrogel component (plug) attached to the distal end of the
insert. The hydrogel plug absorbs intrauterine fluids (i.e., water or saline)
soon after placement, causing the hydrogel to swell, conform to the fallopian
tube, and acutely occlude the target fallopian tube within one hour.
Study objective
Evaluate the safety and effectiveness of the Essure System for Permanent Birth
Control (Model ESS505) in preventing pregnancy
Study design
This is a multi-center, multi-national clinical study to evaluate the safety
and effectiveness of the ESS505 device to prevent pregnancy in women who are
seeking permanent contraception.
Approximately 600 female subjects will be continuously enrolled in the study to
receive the ESS505 and will be evaluated periodically for up to 1 year for
pregnancy and AEs. Subjects will be followed for safety and efficacy for up to
10 years.
In order to evaluate the safety and effectiveness of ESS505 in preventing
pregnancy, the study will have 2 co-primary endpoints and 3 secondary
endpoints.
Intervention
• non-incisional permanent birth control (female sterilization) by occlusion of
the fallopian tubes
• Subject will undergo insert placement procedure.
• Insert location will be evaluated and validated via Essure
Confirmation Test performed post successful insert placement. Transvaginal
Ultrasound (TVU) is the intended first-line confirmation test. If procedural
events suggest the need for a hysterosalpingogram (HSG),as defined in the
Essure Confirmation Test protocol, or the TVU confirmation test is equivocal
or unsatisfactory, the insert placement and tubal occlusion will be evaluated by
HSG. Upon a satisfactory confirmation test, subject will be instructed to rely
on Essure for contraception.
Study burden and risks
Advantage: permanent contraception and no additional use of contraception
during the first 3 months.
Risks:
- Pain, or cramps, vaginal blood loss, nausea or vomiting, fainting and / or
dizziness just after the installation process.
- Possible perforation during the placement procedure fallopian tubes uterus,
intestines, bladder, and blood vessels.
- Excessive moisture absorption due to the salt solution, during the placement.
- infections
- Shift of the device,
- Allergic reaction to the device
burdens:
- placement proceduer
- Follow-up visits
- Contact via phone or email
- Record of the first day of menstruation monthly
Bayer HealthCare LLC 1011 McCarthy Boulevard
CA Milpitas 95035
US
Bayer HealthCare LLC 1011 McCarthy Boulevard
CA Milpitas 95035
US
Listed location countries
Age
Inclusion criteria
females 21-44 years
seeking permanent contraception
body weight 40-136 kg
sexually active
willing accept risk of pregnancy
medical physical history indicating bilateral viable & patient fallopian tubes
able to comply with 10 year FU visits
Exclusion criteria
known proximal tubal occlusion
ondergone fallopian tube sterilization
diagnosed endometrial or myometrial pathology
post-menopausal
upper or lower pelvic infection
suspected or confirmed pregnancy
gynecologic malignancy
pregnancy termination less then 6 weeks prior insert p0lacement
known allergy to all contrast media for use in HSG
unicornuate uterus
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 |
|---|---|
| ClinicalTrials.gov | NCT01948882 |
| CCMO | NL46730.075.13 |