check_circleStudy Completed
Contraception
Bayer Identifier:
17035
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
ESS505 Pre-hysterectomy Protocol
Trial purpose
This study has been designed to evaluate an investigational model of the Essure System for Permanent Birth Control. The investigational device is designed to offer all the advantages of the currently approved device. In addition, the investigational device offers immediate, permanent contraception without a three-month waiting period or 90-day confirmation test. This study has been designed to evaluate the effectiveness of the investigational device in causing tubal occlusion from insert placement through three months of wearing.
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
66Trial Dates
July 2012 - March 2013Phase
N/ACould I Receive a placebo
NoProducts
ESS505 (BAY1454033)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Regina, S4P 0W5, Canada | |
Completed | Chihuahua, 31350, Mexico |
Primary Outcome
- Number of occluded fallopian tubes 60 minutes after placement of the insert as measured by an HSG evaluationHysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.date_rangeTime Frame:60 minutes after insert placementenhanced_encryptionNoSafety Issue:
- Number of occluded fallopian tubes 30 days following placement as measured by an HSG evaluationHysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.date_rangeTime Frame:30 days after insert placementenhanced_encryptionNoSafety Issue:
- Number of occluded fallopian tubes 60 days following placement as measured by an HSG evaluationHysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.date_rangeTime Frame:60 days after insert placementenhanced_encryptionNoSafety Issue:
- Number of occluded fallopian tubes 90 days following placement as measured by an HSG evaluationHysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.date_rangeTime Frame:90 days after insert placementenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2