Contraception
Conditions
Keywords
permanent contraception, birth control, pregnancy prevention
Brief summary
The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.
Interventions
DEVICEFemBloc
Treatment with FemBloc for women who desire permanent birth control (female sterilization)
Sponsors
Femasys Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, 21 - 45 years of age desiring permanent birth control * Sexually active with male partner * Regular menstrual cycle for last 3 months or on hormonal contraceptives
Exclusion criteria
* Uncertainty about the desire to end fertility * Known or suspected pregnancy * Prior tubal surgery, including sterilization attempt * Prior endometrial ablation * Presence, suspicion, or previous history of gynecologic malignancy * Abnormal uterine bleeding requiring evaluation or treatment * Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s) * Allergy to shellfish, betadine or iodinated contrast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reliance Rate | within 1 year | Number of subjects told to rely divided by number of qualified subjects |
| Concordance | within 1 year | Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation |
Countries
United States
Outcome results
None listed