ESS505 Pre-hysterectomy Protocol

NCT ID: NCT01664052

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-03-31

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.

Conditions

Contraception

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

ESS505-A (Essure, BAY1454033)

Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.

Group Type: EXPERIMENTAL

ESS505-A (Essure, BAY1454033)

Intervention Type: DEVICE

Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.

ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)

Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.

Group Type: EXPERIMENTAL

ESS505 (Essure, BAY1454033)

Intervention Type: DEVICE

Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.

ESS305 (Essure, BAY1454032)

Intervention Type: DEVICE

Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.

Interventions

ESS505 (Essure, BAY1454033)

Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.

Intervention Type: DEVICE

ESS305 (Essure, BAY1454032)

Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.

Intervention Type: DEVICE

ESS505-A (Essure, BAY1454033)

Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Regina, Saskatchewan, Canada

Chihuahua City, Chihuahua, Mexico

Countries

Canada; Mexico

References

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.

Reference Type: BACKGROUND

PMID: 24861649 (View on PubMed)

Other Identifiers

ESS505-002

Identifier Type: OTHER

Identifier Source: secondary_id

17035

Identifier Type: -

Identifier Source: org_study_id