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

November 2, 2026 updated by: Femasys Inc.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain
        • Hospital Materno Infantil de Badajoz
      • Barakaldo, Spain
        • Hospital Universitario de Cruces
      • Bilbao, Spain
        • Hospital Universitario Basurto
      • Burgos, Spain
        • Hospital Universitario de Burgos
      • Córdoba, Spain
        • Hospital Universitario Reina Sofía
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves
      • Las Palmas de Gran Canaria, Spain
        • Hospital Universitario Materno Infantil de Canarias
      • Lleida, Spain
        • Hospital Arnau de Vilanova
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Majadahonda, Spain
        • Hospital Universitario Puerta De Hierro
      • Móstoles, Spain
        • Hospital Universitario de Móstoles
      • Salamanca, Spain
        • Hospital Clínico Universitario de Salamanca
      • San Sebastián, Spain
        • Hospital Universitario Donostia
      • San Sebastián de los Reyes, Spain
        • Hospital Universitario Infanta Sofía
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Seville, Spain
        • Hospital Universitario Virgen Macarena
      • Seville, Spain
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain
        • Hospital Universitario y Politécnico La Fe
      • Zaragoza, Spain
        • Hospital Lozano Blesa
    • La Rioja
      • Logroño, La Rioja, Spain
        • Hospital Universitario San Pedro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Females of child-bearing age who desire permanent birth control

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FemBloc

Device
Device: FemBloc Permanent Birth Control

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At time of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of device- and/or procedure-related safety events
Time Frame: At the time of procedure and up through 3 months post procedure

Number of participants with device- and/or procedure-related adverse events
At the time of procedure and up through 3 months post procedure
Pain
Time Frame: At the time of procedure

Measure the degree of pain reported by participants on Visual Analog Scale (0-10 scale, 10 = intense pain)
At the time of procedure
Bilateral occlusion rate
Time Frame: 3 months post procedure

Rate of bilateral tubal occlusion using saline-air contrast ultrasound
3 months post procedure
Pregnancy rate
Time Frame: 12 months post procedure and confirmation test

Rate of pregnancies among the participants
12 months post procedure and confirmation test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Femasys Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

October 23, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FemBlocEsp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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