ContraceptionNCT07924293
A Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method
An observational study of Contraception, run by Femasys Inc. at 20 sites in Spain.
Trial summary
A Prospective Observational Pilot Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method in Spain Read more about this study
- Who is it for?
- Ages 21 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 20 sitesSpain
- Study dates
- 22 Oct 2025to Jul 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females of child-bearing age who desire permanent birth control
Who may be able to join
- Women between 21 and 49 years old with a desire for permanent contraception
- No desire for future motherhood
- Capacity to give informed consent
- Candidates for the FemBloc procedure according to medical assessment
- Willing to continue using their alternative method of contraception until confirmation of occlusion
- Women who have had the FemBloc procedure performed by clinical practice as of August 1, 2025, that meet all other inclusion and none of the exclusion criteria, and that have medical records collected with the necessary information for the study in order to comply with it
Who cannot join
- Previous tubal surgery
- Ectopic pregnancy
- Uterine malformations or difficulties in cervical canalization
- Active or recent genital infection
- Known hypersensitivity to the polymer or formaldehyde
- Postpartum or abortion within the last 6 weeks
- Undiagnosed abnormal uterine bleeding
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Hospital Materno Infantil de Badajoz
Badajoz
Hospital Universitario de Cruces
Barakaldo
Hospital Universitario Basurto
Bilbao
Hospital Universitario de Burgos
Burgos
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario Virgen de las Nieves
Granada
Hospital Universitario Materno Infantil de Canarias
Las Palmas de Gran Canaria
Hospital Arnau de Vilanova
Lleida
Hospital Universitario San Pedro
Logroño, La Rioja
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta De Hierro
Majadahonda
Hospital Universitario de Móstoles
Móstoles
Hospital Clínico Universitario de Salamanca
Salamanca
Hospital Universitario Donostia
San Sebastián
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Universitario Virgen del Rocío
Seville
Hospital Universitario Virgen Macarena
Seville
Hospital Universitario y Politécnico La Fe
Valencia
Hospital Lozano Blesa
Zaragoza
About this study
Official title: SAFE: Surveillance And Follow-up Evaluation of FemBloc
A Prospective Observational Pilot Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method in Spain
Read the detailed description
A Prospective Observational Pilot Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method in Spain
- Conditions
- Contraception
- Being tested
- FemBloc Permanent Birth Control
- Keywords
- Permanent Birth Control, Permanent Contraception, Permanent Sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemBloc Permanent Birth ControlDevice
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
| Study group | Role | What they receive |
|---|---|---|
| FemBloc | Device Receives: Device: FemBloc Permanent Birth Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of patient satisfaction
To evaluate the acceptance of the FemBloc procedure in real life by female candidates by measuring the degree of satisfaction reported by participants on Likert scale (1-5, 5=highest satisfaction)
Measured: At time of procedure
Secondary outcomes (4)
Evaluation of device- and/or procedure-related safety events
Number of participants with device- and/or procedure-related adverse events
Measured: At the time of procedure and up through 3 months post procedure
Pain
Measure the degree of pain reported by participants on Visual Analog Scale (0-10 scale, 10 = intense pain)
Measured: At the time of procedure
Bilateral occlusion rate
Rate of bilateral tubal occlusion using saline-air contrast ultrasound
Measured: 3 months post procedure
Pregnancy rate
Rate of pregnancies among the participants
Measured: 12 months post procedure and confirmation test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start22 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionJul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Femasys Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924293
- Sponsor's protocol ID
- FemBlocEsp
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- 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 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFE: Surveillance And Follow-up Evaluation of FemBloc
- ClinicalTrials.gov ID
- NCT07924293
- Acronym / sponsor ID
- FemBlocEsp
- Conditions
- Contraception
- Keywords
- Permanent Birth Control, Permanent Contraception, Permanent Sterilization
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Femasys Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Nov 2026 (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.
A Prospective Observational Pilot Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method in Spain
Detailed description
A Prospective Observational Pilot Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method in Spain
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FemBloc | – | Device: FemBloc Permanent Birth ControlDevice |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females of child-bearing age who desire permanent birth control
Key inclusion criteria (6 listed)
- Women between 21 and 49 years old with a desire for permanent contraception
- No desire for future motherhood
- Capacity to give informed consent
- Candidates for the FemBloc procedure according to medical assessment
- Willing to continue using their alternative method of contraception until confirmation of occlusion
Key exclusion criteria (7 listed)
- Previous tubal surgery
- Ectopic pregnancy
- Uterine malformations or difficulties in cervical canalization
- Active or recent genital infection
- Known hypersensitivity to the polymer or formaldehyde
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 Birth ControlTreatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes. | Device | FemBloc |
Primary outcome
Degree of patient satisfaction
Time frame: At time of procedure
To evaluate the acceptance of the FemBloc procedure in real life by female candidates by measuring the degree of satisfaction reported by participants on Likert scale (1-5, 5=highest satisfaction)
4 secondary outcomes
Evaluation of device- and/or procedure-related safety events
Time frame: At the time of procedure and up through 3 months post procedure
Pain
Time frame: At the time of procedure
Bilateral occlusion rate
Time frame: 3 months post procedure
Pregnancy rate
Time frame: 12 months post procedure and confirmation test
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 9 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Femasys Inc. at 20 sites in Spain.
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 6 inclusion and 7 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 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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?
Degree of patient satisfaction (time frame: At time of procedure). 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 9 Nov 2026.