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

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

NCT03127722

18894

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)

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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