Trial Condition(s):

Contraception

ESS505 Design Evaluation Study

Bayer Identifier:

18017

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The Essure system consists of the micro-insert and a disposable delivery system and has undergone clinical investigation since 1996. The Essure ESS305 system received FDA approval in 2002 (PO20014) and is commercially available in the United States, Canada, Europe (CE Mark approval received 01-June-2004), Australia, Singapore and Mexico.
The basic mechanism for Essure ESS505 insert detachment and deployment remains the same; however, the ESS505 delivery system is re-designed to accommodate the addition of a hydrogel plug on the distal end of the micro-insert. The hydrogel is designed to cause immediate occlusion of the fallopian tubes and thus, provide immediate contraception (after a confirmation test that confirms micro-insert location and retention).

Inclusion Criteria
-  Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy (LAVH), Total Abdominal Hysterectomy (TAH) with Bilateral Partial Salpingectomy or Bilateral Salpingo-oophorectomy (BSO) for benign uterine pathology.
 -  Subjects who are 18 years of age and older.
 -  Subjects who are able and willing to provide written informed consent.
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 uterine or other gynecologic cancers.

Trial Summary

Enrollment Goal
20
Trial Dates
black-arrow
Phase
n/a
Could I receive a placebo?
No
Products
ESS505 (BAY1454033)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Hospital Central Universitario

Chihuahua, Mexico, 31350

Status
Completed
 

Trial Design