ESS505 Pre-hysterectomy Protocol

Contraception Clinical Trial

Official title:

ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664052
• Other study ID #: 17035
• Secondary ID: ESS505-002
• Status: Completed
• Phase: N/A
• First received: August 7, 2012
• Last updated: May 18, 2016
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaMexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Canada,  Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation	Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.	60 minutes after insert placement	No
Primary	Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation	Hysterosalpingogram (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.	30 days after insert placement	No
Primary	Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation	Hysterosalpingogram (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.	60 days after insert placement	No
Primary	Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation	Hysterosalpingogram (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.	90 days after insert placement	No

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