ClinicalTrials.gg
Active, not recruitingNCT07924293Updated Nov 9, 2026

A Study to Evaluate the Acceptability of the FemBloc System as a Non-surgical, Permanent Contraceptive Method

An observational study in Contraception, sponsored by Femasys Inc.. Active, not recruiting at 20 sites in Spain. Open to female participants aged 21 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Femasys Inc. · Observational

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
21 Years to 49 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Contraception

Keywords

  • Permanent Birth Control
  • Permanent Contraception
  • Permanent Sterilization
03

In context

Lead sponsor

Femasys Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Females of child-bearing age who desire permanent birth control

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women between 21 and 49 years old with a desire for permanent
  • No desire for future motherhood
  • Capacity to give
  • 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

Exclusion criteria

Exclusion Criteria:

  • Previous tubal surgery
  • Ectopic pregnancy
  • Uterine malformations or difficulties in cervical canalization
  • Active or recent genital infection
  • Known to the polymer or formaldehyde
  • Postpartum or abortion within the last 6 weeks
  • Undiagnosed abnormal uterine bleeding
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • FemBloc

    Device

    Device: FemBloc Permanent Birth Control

Interventions

  • DeviceFemBloc Permanent Birth Control

    Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: At time of procedure

Secondary outcomes

  1. Evaluation of device- and/or procedure-related safety events

    Number of participants with device- and/or procedure-related adverse events

    Time frame: At the time of procedure and up through 3 months post procedure

  2. Pain

    Measure the degree of pain reported by participants on Visual Analog Scale (0-10 scale, 10 = intense pain)

    Time frame: At the time of procedure

  3. Bilateral occlusion rate

    Rate of bilateral tubal occlusion using saline-air contrast ultrasound

    Time frame: 3 months post procedure

  4. Pregnancy rate

    Rate of pregnancies among the participants

    Time frame: 12 months post procedure and confirmation test

07

Study locations

20 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Apr 2027, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2026
First posted
Nov 9, 2026
StartActual
Oct 22, 2025
Primary completionEst.
Apr 2027
CompletionEst.
Jul 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924293
Lead sponsor
Femasys Inc.
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Oct 22, 2025
Primary completion
Apr 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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