ESS505 Pre-hysterectomy Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01664052
First received: August 7, 2012
Last updated: May 18, 2016
Last verified: May 2016
  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.

Condition Intervention
Contraception
Device: ESS505 (Essure, BAY1454033)
Device: ESS305 (Essure, BAY1454032)
Device: ESS505-A (Essure, BAY1454033)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation [ Time Frame: 60 minutes after insert placement ] [ Designated as safety issue: No ]
    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.

  • Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation [ Time Frame: 30 days after insert placement ] [ Designated as safety issue: No ]
    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.

  • Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation [ Time Frame: 60 days after insert placement ] [ Designated as safety issue: No ]
    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.

  • Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation [ Time Frame: 90 days after insert placement ] [ Designated as safety issue: No ]
    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.


Enrollment: 66
Study Start Date: July 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: 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.
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.
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664052

Locations
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4P 0W5
Mexico
Chihuahua, Mexico, 31350
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01664052     History of Changes
Other Study ID Numbers: 17035  ESS505-002 
Study First Received: August 7, 2012
Results First Received: February 3, 2016
Last Updated: May 18, 2016
Health Authority: Canada: Health Canada
Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:
Polystyrene sulfonic acid
Terephthalic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016