FemBloc® Permanent Contraception

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-02

Study Completion Date

2025-07-31

Brief Summary

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Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FemBloc

Investigational device and procedure

Group Type EXPERIMENTAL

FemBloc

Intervention Type DEVICE

Treatment with FemBloc for women who desire permanent birth control (female sterilization)

Control

Laparoscopic bilateral tubal sterilization

Group Type ACTIVE_COMPARATOR

Laparoscopic bilateral tubal sterilization

Intervention Type PROCEDURE

Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

Interventions

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FemBloc

Treatment with FemBloc for women who desire permanent birth control (female sterilization)

Intervention Type DEVICE

Laparoscopic bilateral tubal sterilization

Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female, 21 - 45 years of age desiring permanent birth control
* Sexually active with male partner
* For FemBloc Arm:

* Regular menstrual cycle for last 3 months or on hormonal contraceptives
* For Control Arm:

* Undergoing planned laparoscopic bilateral tubal sterilization

Exclusion Criteria

* Uncertainty about the desire to end fertility
* Known or suspected pregnancy
* Prior tubal surgery, including sterilization attempt
* Prior endometrial ablation
* Presence, suspicion, or previous history of gynecologic malignancy
* Abnormal uterine bleeding requiring evaluation or treatment
* Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes