Clinical trial NCT01664052: ESS505 Pre-hysterectomy Protocol
Official title: ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: This study has previously been posted by Conceptus, Inc. (US).

After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation
timeFrame: 60 minutes after insert placement
measure: Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation
timeFrame: 30 days after insert placement
measure: Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation
timeFrame: 60 days after insert placement
measure: Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation
timeFrame: 90 days after insert placement
Secondary outcomes:
Other outcomes:
Locations:
city: Regina
country: Canada
state: Saskatchewan
city: Chihuahua
country: Mexico
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Thiel J, Rattray D, Cher DJ. Pre-hysterectomy assessment of immediate tubal occlusion with the third-generation ESSURE insert (ESS505). J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):1055-60. doi: 10.1016/j.jmig.2014.04.020. Epub 2014 May 24.