Trial Condition(s):
Contraception
ESS505 Design Evaluation Study
Bayer Identifier:
18017
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The Essure system consists of the micro-insert and a disposable delivery system and has undergone clinical investigation since 1996. The Essure ESS305 system received FDA approval in 2002 (PO20014) and is commercially available in the United States, Canada, Europe (CE Mark approval received 01-June-2004), Australia, Singapore and Mexico.
The basic mechanism for Essure ESS505 insert detachment and deployment remains the same; however, the ESS505 delivery system is re-designed to accommodate the addition of a hydrogel plug on the distal end of the micro-insert. The hydrogel is designed to cause immediate occlusion of the fallopian tubes and thus, provide immediate contraception (after a confirmation test that confirms micro-insert location and retention).
Inclusion Criteria
- Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy (LAVH), Total Abdominal Hysterectomy (TAH) with Bilateral Partial Salpingectomy or Bilateral Salpingo-oophorectomy (BSO) for benign uterine pathology. - Subjects who are 18 years of age and older. - Subjects who are able and willing to provide written informed consent.
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 uterine or other gynecologic cancers.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hospital Central Universitario Chihuahua, Mexico, 31350 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
ESS505 Design Evaluation Study
Trial Type:
Interventional
Intervention Type:
Device
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Ability to track and place the ESS505 micro-insert in the proximal portion of the fallopian tube, ideally so that the outer coil spans the utero-tubal junction (UTJ)Bilateral placement of the Essure ESS505 micro-insertTimeframe: Day 0
- Ability of the insert to detach from the delivery systemBilateral placement of the Essure ESS505 micro-insertTimeframe: Day 0
- Stability of the hydrogel/micro-insert within the fallopian tube until the hysterectomy procedureHysterosalpingogram (HSG) at 0 and 90 days after placement of the micro-insertTimeframe: 0-90 days after placement of the micro-insert
- Ability of the micro-insert to occlude the fallopian tube 60 minutes after placementHysterosalpingogram (HSG) at 60 minutes after placement of the micro-insertTimeframe: 60 minutes after placement of micro-insert
- Ability of the hydrogel to occlude the tube through 12 weeks following placementHysterosalpingogram (HSG) at 90 days after placement of the micro-insertTimeframe: 0-90 days following placement of the micro-insert
- Histologic evaluation and descriptive presentation of histology from fallopian tube specimens with inserts in situ including local tissue reactionHistological evaluation of the fallopian tube after hysterectomyTimeframe: Approximately Day 90
Secondary Outcome
- Subject’s tolerance and recovery from the micro-insert placement procedure, including evaluation of AEs and SAEsThe Investigator’s assessment at the time of the micro-insert placement procedure and at each follow-up evaluation visitTimeframe: 0-90 days following placement of the micro-insert
Additional Information
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