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Tanner Clinic | Research Department

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Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

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Bayer

Status

Active, not recruiting

Conditions

Contraception

Treatments

Device: ESSURE (BAY1454032)
Procedure: Laparoscopic tubal sterilization
Procedure: Blood draw

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including:

  • Pelvic and/or lower abdominal pain
  • Abnormal uterine bleeding
  • Surgical intervention (including "insert removal" and hysterectomy)
  • Allergic, hypersensitivity, or autoimmune-like reactions

Enrollment

990 patients

Sex

Female

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects who are at least 21 years of age;

  • Subjects of all weights will be included;

  • Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling.

  • For the Essure group only:

    • Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU;

  • For the laparoscopic tubal sterilization group only:

    • Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care.

Exclusion criteria

  • Subjects who are post-menopausal;
  • Subjects suspected of being or confirmed pregnant;
  • Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled procedure;
  • Subjects uncertain about ending fertility;
  • Subjects with an active upper or lower genital tract infection;
  • Subjects with gynecologic malignancy (suspected or known);
  • Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic);
  • Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization;
  • Subjects with unexplained vaginal bleeding.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

990 participants in 2 patient groups

ESSURE (BAY1454032)
Experimental group
Description:
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented.
Treatment:
Procedure: Blood draw
Device: ESSURE (BAY1454032)
Laparoscopic tubal sterilization
Active Comparator group
Description:
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
Treatment:
Procedure: Blood draw
Procedure: Laparoscopic tubal sterilization

Trial contacts and locations

57

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Data sourced from clinicaltrials.gov

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