ContraceptionBLOCNCT04273594
FemBloc® Permanent Contraception - Confirmation Feasibility Trial
A study testing FemBloc in people with Contraception, run by Femasys Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- FemBloc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Feb 2020to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University Hospitals - Cleveland Medical Center
Beachwood, Ohio, 44122
New Horizons Clinical Trials
Chandler, Arizona, 85224
Midtown OB GYN North
Columbus, Georgia, 31909
Women's Health Advantage
Fort Wayne, Indiana, 46825
Precision Trials AZ, LLC
Phoenix, Arizona, 85032
Saginaw Valley Medical Research Group
Saginaw, Michigan, 48604
About this study
Official title: BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)
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.
- Conditions
- Contraception
- Being tested
- FemBloc
- Keywords
- permanent contraception, birth control, pregnancy prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemBlocDevice
Treatment with FemBloc for women who desire permanent birth control (female sterilization)
| Study group | Role | What they receive |
|---|---|---|
| FemBloc | Experimental | Investigational device and procedure Receives: Device: FemBloc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliance Rate
Number of subjects told to rely divided by number of qualified subjects
Measured: within 1 year
Concordance
Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start27 Feb 2020
- Primary completion30 Sep 2022
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Femasys Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273594
- Sponsor's protocol ID
- CP-100-008
- Acronym
- BLOC
- Status last verified
- Jan 2025
- First submitted
- 14 Feb 2020
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)
- ClinicalTrials.gov ID
- NCT04273594
- Acronym / sponsor ID
- BLOC / CP-100-008
- Conditions
- Contraception
- Keywords
- permanent contraception, birth control, pregnancy prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Femasys Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FemBloc | Experimental | Device: FemBlocInvestigational device and procedure |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemBlocTreatment with FemBloc for women who desire permanent birth control (female sterilization) | Device | FemBloc |
Primary outcome
Reliance Rate
Time frame: within 1 year
Number of subjects told to rely divided by number of qualified subjects
Concordance
Time frame: within 1 year
Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemBloc in people with Contraception, run by Femasys Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliance Rate (time frame: within 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.