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ESS310

Phase 3

Contraception | Unknown | Endocrine |Bayer AG|Last Updated: Apr 8, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment134

FDA Designations

No designations recorded

Clinical trial landscape

ESS310 · 1 trial · 1 indication

Phase 3 1
NCT02064413Essure (Model ESS310) Placement Rate StudyContraception
COMPLETED134 Analytics
PHASE3COMPLETED
Essure (Model ESS310) Placement Rate Study
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
Day 1

Secondary Endpoints

Successful bilateral placement rate of the ESS310 insert at first attempt in all subjects who undergo hysteroscopy with the intent of having bilateral ESS310 placement
Day 1
Evaluation of investigator questionnaire regarding ESS310 design and usability
Day 1
Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt
Day 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
ESS310EXPERIMENTALAll subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.

Interventions

NameTypeDescription
ESS310 (BAY1454032)DEVICE -
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Eligibility Criteria

Age Range21 Years to 44 Years
SexFEMALE
Healthy VolunteersYes
Study Sites16

Inclusion Criteria: * Females aged range 21 to 44 years * Subjects seeking permanent contraception * Subjects with body weight within range of 90-300 pounds (40 - 136 kilograms) * Subjects for whom medical history indicates bilateral viable and patent fallopian tubes * Subjects are able and willing...

Countries:United States
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Frequently asked questions about ESS310

What is ESS310 used for?

ESS310 is an investigational device being studied for contraception. It was evaluated in a Phase 3 clinical trial in the United States. The study, NCT02064413, was a placement rate study for the Essure Model ESS310, and it has been completed.

Who makes ESS310?

ESS310 is developed by Bayer AG, which trades under the ticker BAYRY. The company conducted a Phase 3 clinical trial for this contraceptive device in the United States.

What phase is ESS310 in?

ESS310 is in Phase 3 clinical development. A Phase 3 trial, NCT02064413, has been completed. This trial was an uncontrolled study that enrolled 134 female participants aged 21 years and older.

What clinical trials is ESS310 in?

ESS310 has one completed clinical trial, NCT02064413, titled "Essure (Model ESS310) Placement Rate Study." This Phase 3 study was conducted in the United States and enrolled 134 healthy female volunteers for contraception.

Is ESS310 the same as Essure?

ESS310 is a model of the Essure device. The clinical trial NCT02064413 is titled "Essure (Model ESS310) Placement Rate Study," indicating that ESS310 is a specific version of the Essure contraceptive system.