N/A
N=31
ESS505 Pre-hysterectomy Protocol
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01664052 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation — 36; NA; NA; NA Occluded fallopian tubes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ESS505 (Essure, BAY1454033) (Device); ESS305 (Essure, BAY1454032) (Device); ESS505-A (Essure, BAY1454033) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation |
36; NA; NA; NA; 3; NA | — |
| PRIMARY Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation |
15; NA; NA; NA; 10; NA | — |
| PRIMARY Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation |
12; NA; NA; NA; 10; NA | — |
| PRIMARY Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation |
10; NA; NA; NA; 10; NA | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy (LAVH), Total Abdominal Hysterectomy (TAH), Total Vaginal Hysterectomy (TVH), Total Laparoscopic Hysterectomy (TLH) with Bilateral Total Salpingectomy or Bilateral Salpingo-oophorectomy (BSO), or Laparoscopic Supracervical Hysterectomy (LSH)
- Subjects who are 18 years of age and older
- Subjects who are able and willing to provide written informed consent
- Subjects who agree to use a contraceptive method following Essure placement until the hysterectomy procedure
Exclusion Criteria
- Subjects with bilateral proximal tubal occlusion
- Subjects who have undergone fallopian tube sterilization
- Subjects with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia
- Subjects who are post-menopausal
- Subjects with pelvic inflammatory disease (PID)
- Subjects with gynecologic malignancy
- Pregnancy or suspected pregnancy
- Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement
- Known allergy to contrast media
- Any general health condition that may represent, in the opinion of the Investigator, an increased potential risk associated with participation
Data sourced from ClinicalTrials.gov (NCT01664052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.