Prospective Multi-Center Trial for FemBloc Permanent Birth Control

NCT ID: NCT05977751

Last Updated: 2025-01-28

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

RECRUITING

Clinical Phase

NA

Total Enrollment

573 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2031-06-30

Brief Summary

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Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Detailed Description

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Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

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 for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.

Interventions

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FemBloc

Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female, 21 - 50 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.
* Presence, suspicion, or previous history of gynecologic malignancy.
* Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
* Abnormal uterine bleeding requiring evaluation or treatment.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Femasys Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Sponsor

Role: STUDY_DIRECTOR

Medical Affairs and Clinical Development

Locations

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Stanford University

Palo Alto, California, United States

Site Status RECRUITING

University of California Davis

Sacramento, California, United States

Site Status RECRUITING

Midtown OB GYN North

Columbus, Georgia, United States

Site Status RECRUITING

Maimonides Medical Center

Brooklyn, New York, United States

Site Status RECRUITING

Seven Hills Women's Health Centers

Cincinnati, Ohio, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Director

Role: CONTACT

770-500-3910 Ext. 146

Facility Contacts

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Research Coordinator

Role: primary

650-497-5175

Research Coordinator

Role: primary

916-734-6846

Research Coordinator

Role: primary

706-320-2547

Research Coordinator

Role: primary

718-283-7962

Research Coordinator

Role: primary

513-290-3221

Research Coordinator

Role: primary

801-231-2774

Related Links

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http://www.fembloc.com/

FemBloc Clinical Study Website

Other Identifiers

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CP-100-009

Identifier Type: -

Identifier Source: org_study_id

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