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Procedure

FemBloc for Permanent Birth Control (FINALE Trial)

N/A

Recruiting

Research Sponsored by Femasys Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five (5) years

Awards & highlights

FINALE Trial Summary

This trial tests a new approach to female sterilization, using ultrasound to confirm results.

Who is the study for?

This trial is for women aged 21-50 who want permanent birth control. They must have had a regular menstrual cycle in the last three months or be on hormonal contraceptives, and be sexually active with a male partner. Women can't join if they're pregnant, have had previous tubal surgeries, are planning other uterine procedures before confirmation tests, have abnormal bleeding issues, are unsure about ending fertility, or have current or past gynecologic cancers.Check my eligibility

What is being tested?

The study is testing FemBloc as a method of permanent birth control. It's an international single-arm trial where all participants receive FemBloc followed by ultrasound tests to confirm its effectiveness.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include discomfort during the procedure, potential allergic reactions to materials used in FemBloc, and possible failure leading to unintended pregnancy.

FINALE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five (5) years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five (5) years

This trial's timeline: 3 weeks for screening, Varies for treatment, and five (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

Pregnancy Rate

Secondary outcome measures

Long term Pregnancy Rate

Reliance Rate

FINALE Trial Design

1Treatment groups

Experimental Treatment

Group I: FemBlocExperimental Treatment1 Intervention

Investigational device and procedure

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Femasys Inc.Lead Sponsor

5 Previous Clinical Trials

548 Total Patients Enrolled

Study SponsorStudy DirectorMedical Affairs and Clinical Development

Media Library

FemBloc (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05977751 — N/A

Birth Control Research Study Groups: FemBloc

Birth Control Clinical Trial 2023: FemBloc Highlights & Side Effects. Trial Name: NCT05977751 — N/A

FemBloc (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05977751 — N/A

Frequently Asked Questions

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

Could adolescents aged 35 years and below partake in this trial?

"Eligibility for this experiment is limited to participants aged between 21 and 50. Conversely, there are 20 medical trials available for individuals younger than 18 years old, as well as 15 studies available for those over 65."

Answered by AI

Are new candidates able to join this research endeavor?

"Affirmative, there is evidence to suggest that this trial is actively seeking participants. Clinicaltrials.gov displays the original posting date of August 1st 2023 and the most recent update on 8/3/2023. This research endeavour requires 573 individuals at a single medical centre."

Answered by AI

Could I potentially qualify for the research study?

"This medical trial requires all participating patients be between 21 and 50 years old, while on a form of birth control. Currently 573 individuals are being enrolled."

Answered by AI

What is the current enrollment limit for this clinical trial?

"Confirmative. Clinicaltrials.gov data indicates that this experiment, which was initiated on August 1st 2023, is currently recruiting volunteers. 573 research subjects must be enrolled from a single facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

2023. "Prospective Multi-Center Trial for FemBloc Permanent Birth Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05977751.