Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safety & efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.

Detailed Description
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Participants who demonstrated to be bilaterally occluded by hysterosalpingogram (HSG) evaluations are allowed to rely on the Adiana System for pregnancy prevention and enter the Wearing Period of follow-up. Secondary endpoints inlcude safety of device placement procedure and safety of device wearing. The adverse events recorded during the course of the study are entered under adverse events.

Official Title
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A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial

Conditions
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Reproductive Sterilization

Intervention / Treatment
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* Device: Adiana Transcervical Sterilization System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Women aged 18 to 45 Women who are seeking permanent contraception Women who are at risk of becoming pregnant Willing to risk becoming pregnant when relying on the Adiana device for contraception Relatively normal uterine cavity, uterine wall thickness, and uterine size as demonstrated by pelvic sonography Willing to keep a coital/menstrual log Have at least one confirmed pregnancy and one living child Monogamous relationship with a partner who has proven fertility Sexually active (at least 4 acts of intercourse per month) Willing to use alternate contraception (either a barrier method or oral contraceptive pills or other monthly, cyclic, hormonal birth control) during the three months following device placement prior to relying on the Adiana device for contraception Willing and able to maintain in regular contact with the investigator Women with regular, cyclical menses within 2 months prior to the device placement procedure Able to provide informed consent Exclusion Criteria: Women who are unsure of their desire to end their fertility Presence of gross genital infection, including sepsis Presence of chlamydia, gonorrhea or syphilis Presence of genital cancer (note: CIN1 is acceptable) Intra-uterine pathology which would prevent optimal access to the tubal ostium and intramural portion of the fallopian tube, such as large submucous fibroids or uterine adhesions History of chronic pelvic pain (present within the previous year), prior ectopic pregnancy, or fallopian tube surgery, or currently diagnosed severe dysmenorrhea, severe dyspareunia, endometriosis, adenomyosis, or pelvic inflammatory disease Women with unresolved tubal, ovarian or endometrial pathology Uterine neoplasia or precursors to neoplasia Dysfunctional uterine bleeding or intermenstrual bleeding within the prior three months Women who have not had at least two normal periods after the following events: irregular periods treated with oral contraceptives (or other monthly, cyclic, hormonal birth control) which have since been discontinued, IUD removal, childbirth, or termination of pregnancy Currently taking immunosuppressive medications including steroids Pregnancy Uterine perforation within the last 3 months Contraindications for surgical methods of sterilization Less than three months have passed since the last delivery or abortion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adiana Transcervical Sterilization System<br>Single arm treatment | Device: Adiana Transcervical Sterilization System<br>* Implantation of silicone matrix in fallopian tubes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 Year Pregnancy Rate | Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Placement Rate | Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement. | After First Treatment Attempt | 
| Device Placement Rate | Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement. | Including Second Treatment Attempt | 
| Patient Satisfaction With Placement Procedure | Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied. | 48 hours | 
| Patient Satisfaction With Device Wearing | Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied. | Waiting Period (1-Month, 2-Months, 3-Months) | 
| Patient Satisfaction With Device Wearing | Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied. | Wearing Period (3-Months, 6-Months, 9-Months, 12-Months) | 
| Patient Comfort With Placement Procedure | Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected. | Post-Procedure | 
| Patient Comfort With Placement Procedure | Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain. | 48 hours | 
| Patient Comfort With Device Wearing | Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort. | Waiting Period (1-Month, 2-Months, 3-Months) | 
| Patient Comfort With Device Wearing | Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort. | Wearing Period (3-Months, 6-Months, 9-Months, 12-Months) | 
| 3 Year Pregnancy Rate | Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female, Sterilization