Trial Condition(s):
Contraception
ESS505 Pre-hysterectomy Protocol
Bayer Identifier:
17035
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study has been designed to evaluate an investigational model of the Essure System for Permanent Birth Control. The investigational device is designed to offer all the advantages of the currently approved device. In addition, the investigational device offers immediate, permanent contraception without a three-month waiting period or 90-day confirmation test. This study has been designed to evaluate the effectiveness of the investigational device in causing tubal occlusion from insert placement through three months of wearing.
Inclusion Criteria
- Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy (LAVH), Total Abdominal Hysterectomy (TAH), Total Vaginal Hysterectomy (TVH), Total Laparoscopic Hysterectomy (TLH) with Bilateral Total Salpingectomy or Bilateral Salpingo-oophorectomy (BSO), or Laparoscopic Supracervical Hysterectomy (LSH) - Subjects who are 18 years of age and older - Subjects who are able and willing to provide written informed consent - Subjects who agree to use a contraceptive method following Essure placement until the hysterectomy procedure
Exclusion Criteria
- Subjects with bilateral proximal tubal occlusion - Subjects who have undergone fallopian tube sterilization - Subjects with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia - Subjects who are post-menopausal - Subjects with pelvic inflammatory disease (PID) - Subjects with gynecologic malignancy - Pregnancy or suspected pregnancy - Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement - Known allergy to contrast media - Any general health condition that may represent, in the opinion of the Investigator, an increased potential risk associated with participation
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Regina, Canada, S4P 0W5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chihuahua, Mexico, 31350 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study
Trial Type:
Interventional
Intervention Type:
Device
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Number of occluded fallopian tubes 60 minutes after placement of the insert as measured by an HSG evaluationHysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.Timeframe: 60 minutes after insert placement
- Number of occluded fallopian tubes 30 days following placement as measured by an HSG evaluationHysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.Timeframe: 30 days after insert placement
- Number of occluded fallopian tubes 60 days following placement as measured by an HSG evaluationHysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.Timeframe: 60 days after insert placement
- Number of occluded fallopian tubes 90 days following placement as measured by an HSG evaluationHysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.Timeframe: 90 days after insert placement
Additional Information
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