check_circleStudy Completed

Contraception

Bayer Identifier:

18017

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
ESS505 Design Evaluation Study

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).

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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.

  • - 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
December 2011 - February 2013
Phase
n/a
Could I Receive a placebo
No
Products
ESS505 (BAY1454033)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hospital Central UniversitarioChihuahua, 31350, Mexico

Primary Outcome

  • Ability to track and place the ESS505 micro-insert in the proximal portion of the fallopian tube, ideally so that the outer coil spans the utero-tubal junction (UTJ)
    Bilateral placement of the Essure ESS505 micro-insert
    date_rangeTime Frame:
    Day 0
    enhanced_encryption
    Safety Issue:
    No
  • Ability of the insert to detach from the delivery system
    Bilateral placement of the Essure ESS505 micro-insert
    date_rangeTime Frame:
    Day 0
    enhanced_encryption
    Safety Issue:
    No
  • Stability of the hydrogel/micro-insert within the fallopian tube until the hysterectomy procedure
    Hysterosalpingogram (HSG) at 0 and 90 days after placement of the micro-insert
    date_rangeTime Frame:
    0-90 days after placement of the micro-insert
    enhanced_encryption
    Safety Issue:
    No
  • Ability of the micro-insert to occlude the fallopian tube 60 minutes after placement
    Hysterosalpingogram (HSG) at 60 minutes after placement of the micro-insert
    date_rangeTime Frame:
    60 minutes after placement of micro-insert
    enhanced_encryption
    Safety Issue:
    No
  • Ability of the hydrogel to occlude the tube through 12 weeks following placement
    Hysterosalpingogram (HSG) at 90 days after placement of the micro-insert
    date_rangeTime Frame:
    0-90 days following placement of the micro-insert
    enhanced_encryption
    Safety Issue:
    No
  • Histologic evaluation and descriptive presentation of histology from fallopian tube specimens with inserts in situ including local tissue reaction
    Histological evaluation of the fallopian tube after hysterectomy
    date_rangeTime Frame:
    Approximately Day 90
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Subject’s tolerance and recovery from the micro-insert placement procedure, including evaluation of AEs and SAEs
    The Investigator’s assessment at the time of the micro-insert placement procedure and at each follow-up evaluation visit
    date_rangeTime Frame:
    0-90 days following placement of the micro-insert
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

ESS505 Design Evaluation Study
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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