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Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

NCT03067272 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-05-09

No results posted yet for this study

Summary

Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.

Conditions

  • Contraception

Interventions

DEVICE

FemBloc® Permanent Contraceptive System

The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Biopolymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).

Sponsors & Collaborators

  • Femasys Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Sponsor Clinical Affairs

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2018-02-27
Completion
2023-03-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03067272 on ClinicalTrials.gov