Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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