ContraceptionBLOCNCT03067272
Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
A study testing FemBloc® Permanent Contraceptive System in people with Contraception, run by Femasys Inc. at 5 sites in United States.
Trial summary
Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy. 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® Permanent Contraceptive System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Mar 2017to 14 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Agreement to use temporary birth control (excluding IUC) until documented occlusion
- Sexually active (minimum of 4 coital acts per month) with male partner who is not known or suspected to be sterile
- At low risk for sexually transmitted infection and / or monogamous
- Reasonably certain subject is not pregnant at time of screening and procedure visits
- Willing to accept the risk of pregnancy while relying solely on FemBloc for contraception
- Signs informed consent agreeing to the protocol requirements and is able to meet the trial schedule
Who cannot join
- Uncertainty about the desire to end fertility
- Suspected or confirmed pregnancy
- Prior tubal surgery
- Uterine anomaly such as unicornuate, bicornuate, arcuate, septate, and didelphic
- Known endometrial or myometrial conditions (e.g. submucous leiomyoma) or uterine position (e.g. retroflexion or anteflexion) that would interfere with insertion tube midline fundal placement, access to uterine cornua, or lateral deployment of the catheters
- Any condition which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented
Show all 16Show fewer
- Active or untreated pelvic infection
- Presence or suspicion of gynecologic malignancy
- Any condition or medical treatment (e.g. systemic corticosteroids or chemotherapy) that compromises immune system
- Post-partum or pregnancy termination <6 weeks of scheduled procedure
- Complicated IUC removal on the day of FemBloc treatment (e.g. use of intracavitary instrument for removal, bleeding, excessive pain)
- Scheduled to undergo concomitant intrauterine procedures at the time of FemBloc treatment or planning any uterine procedure within the 3 months after treatment
- Known hypersensitivity to cyanoacrylate or formaldehyde
- Prior history of ectopic pregnancy
- Abnormal uterine bleeding of unknown etiology
- Any general health condition or systemic disease that may represent, in the Investigator's opinion, a potential increased risk associated with device use or pregnancy, or that would not allow them to complete the trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Chattanooga Medical Research
Chattanooga, Tennessee, 37404
QPS Miami Research Associates
Miami, Florida, 33143
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, 10032
The Stamford Hospital
Stamford, Connecticut, 06904
About this study
Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.
Read the detailed description
Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total. The objective of the study was to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy. Femasys continued follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.
- Conditions
- Contraception
- Being tested
- FemBloc® Permanent Contraceptive System
- Keywords
- Permanent contraception, Birth control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemBloc® Permanent Contraceptive SystemDevice
The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Blended Polymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).
| Study group | Role | What they receive |
|---|---|---|
| FemBloc® Permanent Contraceptive System | Experimental | Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes. Receives: Device: FemBloc® Permanent Contraceptive System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Experience an Adverse Event Divided by the Number of Subjects Exposed to the FemBloc System (Blended Polymer Treatment and Confirmation Test)
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc System. Evaluated up to 3 months after the FemBloc Treatment and Confirmation Test (device and/or procedure related AEs) and then through 5 years.
Measured: 3 months (pilot study safety endpoint and then through 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start15 Mar 2017
- Primary completion27 Feb 2018
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Femasys Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Sponsor Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067272
- Sponsor's protocol ID
- CP-100-006
- Acronym
- BLOC
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2017
- Last updated
- 8 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
- ClinicalTrials.gov ID
- NCT03067272
- Acronym / sponsor ID
- BLOC / CP-100-006
- Conditions
- Contraception
- Keywords
- Permanent contraception, Birth control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Femasys Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 8 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.
Detailed description
Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total. The objective of the study was to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy. Femasys continued follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FemBloc® Permanent Contraceptive System | Experimental | Device: FemBloc® Permanent Contraceptive SystemTreatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female, 21 - 45 years of age desiring permanent birth control
- Agreement to use temporary birth control (excluding IUC) until documented occlusion
- Sexually active (minimum of 4 coital acts per month) with male partner who is not known or suspected to be sterile
- At low risk for sexually transmitted infection and / or monogamous
- Reasonably certain subject is not pregnant at time of screening and procedure visits
Key exclusion criteria (16 listed)
- Uncertainty about the desire to end fertility
- Suspected or confirmed pregnancy
- Prior tubal surgery
- Uterine anomaly such as unicornuate, bicornuate, arcuate, septate, and didelphic
- Known endometrial or myometrial conditions (e.g. submucous leiomyoma) or uterine position (e.g. retroflexion or anteflexion) that would interfere with insertion tube midline fundal placement, access to uterine cornua, or lateral deployment of the catheters
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 |
|---|---|---|
| FemBloc® Permanent Contraceptive SystemThe FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Blended Polymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG). | Device | FemBloc® Permanent Contraceptive System |
Primary outcome
Number of Subjects Who Experience an Adverse Event Divided by the Number of Subjects Exposed to the FemBloc System (Blended Polymer Treatment and Confirmation Test)
Time frame: 3 months (pilot study safety endpoint and then through 5 years)
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc System. Evaluated up to 3 months after the FemBloc Treatment and Confirmation Test (device and/or procedure related AEs) and then through 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Sponsor Clinical Affairs
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemBloc® Permanent Contraceptive System in people with Contraception, run by Femasys Inc. at 5 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 7 inclusion and 16 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: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 8 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Experience an Adverse Event Divided by the Number of Subjects Exposed to the FemBloc System (Blended Polymer Treatment and Confirmation Test) (time frame: 3 months (pilot study safety endpoint and then through 5 years)). 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 8 Sep 2026.