Contraception
Conditions
Keywords
Permanent contraception, Birth control
Brief summary
Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.
Detailed description
Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total. The objective of the study was to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy. Femasys continued follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.
Interventions
DEVICEFemBloc® Permanent Contraceptive System
The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Blended Polymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).
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 * Agreement to use temporary birth control (excluding IUC) until documented occlusion * Sexually active (minimum of 4 coital acts per month) with male partner who is not known or suspected to be sterile * At low risk for sexually transmitted infection and / or monogamous * Reasonably certain subject is not pregnant at time of screening and procedure visits * Willing to accept the risk of pregnancy while relying solely on FemBloc for contraception * Signs informed consent agreeing to the protocol requirements and is able to meet the trial schedule
Exclusion criteria
* Uncertainty about the desire to end fertility * Suspected or confirmed pregnancy * Prior tubal surgery * Uterine anomaly such as unicornuate, bicornuate, arcuate, septate, and didelphic * Known endometrial or myometrial conditions (e.g. submucous leiomyoma) or uterine position (e.g. retroflexion or anteflexion) that would interfere with insertion tube midline fundal placement, access to uterine cornua, or lateral deployment of the catheters * Any condition which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented * Active or untreated pelvic infection * Presence or suspicion of gynecologic malignancy * Any condition or medical treatment (e.g. systemic corticosteroids or chemotherapy) that compromises immune system * Post-partum or pregnancy termination \<6 weeks of scheduled procedure * Complicated IUC removal on the day of FemBloc treatment (e.g. use of intracavitary instrument for removal, bleeding, excessive pain) * Scheduled to undergo concomitant intrauterine procedures at the time of FemBloc treatment or planning any uterine procedure within the 3 months after treatment * Known hypersensitivity to cyanoacrylate or formaldehyde * Prior history of ectopic pregnancy * Abnormal uterine bleeding of unknown etiology * Any general health condition or systemic disease that may represent, in the Investigator's opinion, a potential increased risk associated with device use or pregnancy, or that would not allow them to complete the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Experience an Adverse Event Divided by the Number of Subjects Exposed to the FemBloc System (Blended Polymer Treatment and Confirmation Test) | 3 months (pilot study safety endpoint and then through 5 years) | Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc System. Evaluated up to 3 months after the FemBloc Treatment and Confirmation Test (device and/or procedure related AEs) and then through 5 years. |
Countries
United States
Contacts
STUDY_DIRECTORStudy Director
Sponsor Clinical Affairs
Participant flow
Pre-assignment details
49 subjects enrolled (intent to treat) and 49 subjects had treatment and confirmation test completed; no significant events occurred between enrollment and assignment of participant to group
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 38 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
None listed