FemBloc® Permanent Contraception - Confirmation Feasibility Trial

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-27

Study Completion Date

2027-04-30

Brief Summary

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The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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)

Interventions

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FemBloc

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female, 21 - 45 years of age desiring permanent birth control
* Sexually active with male partner
* Regular menstrual cycle for last 3 months or on hormonal contraceptives

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)
* Allergy to shellfish, betadine or iodinated contrast

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes