FemBloc vs Laparoscopic Sterilization for Birth Control

(BLOC Trial)

Recruiting at 14 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Femasys Inc.

Disqualifiers: Pregnancy, Prior tubal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

240 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on hormonal contraceptives, you may continue them if you are in the FemBloc group.

What data supports the effectiveness of the treatment FemBloc for birth control?

The research on transcervical sterilization using a similar method showed that it was effective in blocking the fallopian tubes in 88.2% of women, with no pregnancies reported among those with successful blockage. This suggests that FemBloc, which may use a similar approach, could be effective for birth control. ^{1 2 3 4 5}

Is laparoscopic sterilization safe for birth control?

Laparoscopic sterilization is generally safe for birth control, with low rates of complications and surgical difficulties. Most women do not experience changes in their menstrual cycles, and the risk of needing further pelvic operations is very low. ^{3 5 6 7 8}

How does the FemBloc treatment differ from other sterilization treatments?

FemBloc is unique because it is a transcervical sterilization method, meaning it is performed through the cervix without the need for incisions, unlike traditional laparoscopic sterilization which requires abdominal incisions. This approach can reduce the risks associated with anesthesia and surgery, making it a simpler and potentially safer option for permanent birth control. ^{1 3 4 6 9}

What is the purpose of this trial?

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.

Research Team

Sponsor

Principal Investigator

Medical Affairs & Clinical Development

Eligibility Criteria

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.

Inclusion Criteria

Regular menstrual cycle for last 3 months or on hormonal contraceptives

I am planning to have a laparoscopic procedure to prevent pregnancy.

I am a woman aged 21-45 and want permanent birth control.

Exclusion Criteria

I have had a procedure to remove the lining of my uterus.

I am unsure about wanting to have children in the future.

Known or suspected pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either FemBloc or laparoscopic bilateral tubal sterilization

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-5 years

Treatment Details

Interventions

• FemBloc
• Laparoscopic Bilateral Tubal Sterilization

Trial Overview 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.

Participant Groups

Group I: FemBloc Experimental Treatment 1 Intervention

Investigational device and procedure

Group II: Control Active Control 1 Intervention

Laparoscopic bilateral tubal sterilization

Who Is Running the Clinical Trial?

Femasys Inc.

Lead Sponsor

Trials

6

Recruited

1,200+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Female sterilization by the vaginal route: a positive reassessment and comparison of 4 tubal occlusion methods. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Postpartum Opportunistic Salpingectomy Compared With Bilateral Tubal Ligation After Vaginal Delivery for Ovarian Cancer Risk Reduction: A Cost-Effectiveness Analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Method failures of laparoscopic tubal sterilization in a residency training program. A comparison of the tubal ring and spring-loaded clip. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Transcervical sterilization with use of methyl 2-cyanoacrylate and a newer delivery system (the FEMCEPT device). [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A comparison of different laparoscopic sterilization occlusion techniques in 24,439 procedures. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Essure hysteroscopic sterilization versus interval laparoscopic bilateral tubal ligation: a comparative effectiveness review. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Hysteroscopic tubal sterilization: a systematic review of the Essure system. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Use of multiple clips for tubal occlusion in interval laparoscopic sterilization: circumstances and consequences. [2019]

9. Croatia pubmed.ncbi.nlm.nih.gov

[Laparoscopic sterilization using tubal rings and clips]. [2009]