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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00737061




Registration number
NCT00737061
Ethics application status
Date submitted
14/08/2008
Date registered
18/08/2008
Date last updated
8/09/2017

Titles & IDs
Public title
Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)
Scientific title
A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial
Secondary ID [1] 0 0
P0071
Universal Trial Number (UTN)
Trial acronym
EASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reproductive Sterilization 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Adiana Transcervical Sterilization System

Experimental: Adiana Transcervical Sterilization System - Single arm treatment


Treatment: Devices: Adiana Transcervical Sterilization System
Implantation of silicone matrix in fallopian tubes
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1 Year Pregnancy Rate
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Device Placement Rate
Timepoint [1] 0 0
After First Treatment Attempt
Secondary outcome [2] 0 0
Device Placement Rate
Timepoint [2] 0 0
Including Second Treatment Attempt
Secondary outcome [3] 0 0
Patient Satisfaction With Placement Procedure
Timepoint [3] 0 0
48 hours
Secondary outcome [4] 0 0
Patient Satisfaction With Device Wearing
Timepoint [4] 0 0
Waiting Period (1-Month, 2-Months, 3-Months)
Secondary outcome [5] 0 0
Patient Satisfaction With Device Wearing
Timepoint [5] 0 0
Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
Secondary outcome [6] 0 0
Patient Comfort With Placement Procedure
Timepoint [6] 0 0
Post-Procedure
Secondary outcome [7] 0 0
Patient Comfort With Placement Procedure
Timepoint [7] 0 0
48 hours
Secondary outcome [8] 0 0
Patient Comfort With Device Wearing
Timepoint [8] 0 0
Waiting Period (1-Month, 2-Months, 3-Months)
Secondary outcome [9] 0 0
Patient Comfort With Device Wearing
Timepoint [9] 0 0
Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)
Secondary outcome [10] 0 0
3 Year Pregnancy Rate
Timepoint [10] 0 0
3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/02/2013
Sample size
Target
Accrual to date
Final
770
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Mexico
State/province [13] 0 0
Nuevo Leon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hologic, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
QST Consultations, Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00737061
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward Evantash, MD
Address 0 0
Hologic, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00737061