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Permanent Contraception

FemBloc vs Laparoscopic Sterilization for Birth Control (BLOC Trial)

N/A
Waitlist Available
Research Sponsored by Femasys Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing planned laparoscopic bilateral tubal sterilization
Female, 21 - 45 years of age desiring permanent birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-5 years
Awards & highlights

BLOC Trial Summary

This trial will compare two methods of female sterilization: FemBloc and laparoscopic tubal sterilization (Control). The trial will last approximately 65 months for the FemBloc group and 62 months for the laparoscopic tubal sterilization (Control) group.

Who is the study for?
This trial is for sexually active women aged 21-45 who want permanent birth control. They must have a regular menstrual cycle or be on hormonal contraceptives and are planning to undergo laparoscopic tubal sterilization. Women unsure about ending fertility, with abnormal bleeding, gynecologic cancer history, pregnancy, or previous tubal surgery can't join.Check my eligibility
What is being tested?
The study compares FemBloc (a new method of permanent contraception) with the standard procedure of laparoscopic bilateral tubal sterilization. It's an international study where participants choose their treatment without being randomly assigned and will be followed up for over five years.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort at the site of procedure, potential complications from surgery like infection or bleeding, and in rare cases device-related issues for those receiving FemBloc.

BLOC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am planning to have a laparoscopic procedure to prevent pregnancy.
Select...
I am a woman aged 21-45 and want permanent birth control.

BLOC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of short-term and long-term adverse events in each arm

BLOC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FemBlocExperimental Treatment1 Intervention
Investigational device and procedure
Group II: ControlActive Control1 Intervention
Laparoscopic bilateral tubal sterilization

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Who is running the clinical trial?

Femasys Inc.Lead Sponsor
5 Previous Clinical Trials
881 Total Patients Enrolled
SponsorStudy DirectorMedical Affairs & Clinical Development

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to become involved in this experiment currently?

"Based on the information posted to clinicaltrials.gov, this medical trial has concluded its patient recruitment process and is no longer seeking applicants; however, 61 other trials are actively enrolling patients currently. This particular study was originally published on February 2nd 2018 with a final edit made April 20th 2022."

Answered by AI

In which geographic areas is this experiment being conducted?

"The Stamford Hospital in Stamford, Connecticut, University of Utah in Salt Lake City, Utah and Wake Research Associates LLC in Raleigh, North carolina are only a few instances of the 15 sites that this trial will be accepting patients from."

Answered by AI

May I partake in this investigation?

"The primary eligibility criteria for this medical trial mandates that participants are between 21 and 45 years old, as well as proficient in contraception methods. The total sample size is expected to reach 240 individuals."

Answered by AI

Does this research endeavor accept participants aged 85 and over?

"This research project is exclusively open to those from 21-45 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FemBloc® Permanent Contraception - Early Pivotal Trial
2018. "FemBloc® Permanent Contraception - Early Pivotal Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03433911.
~33 spots leftby Apr 2025
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