Trial Condition(s):
Contraception
Study to assess outcomes in women undergoing either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization
Bayer Identifier:
18894
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including:
• Pelvic and/or lower abdominal pain
• Abnormal uterine bleeding
• Surgical intervention (including “insert removal” and hysterectomy)
• Allergic, hypersensitivity, or autoimmune-like reactions
Inclusion Criteria
- Subjects who are at least 21 years of age; - Subjects of all weights will be included; - Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling. - For the Essure group only: • Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU; - For the laparoscopic tubal sterilization group only: • Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care.
Exclusion Criteria
- Subjects who are post-menopausal; - Subjects suspected of being or confirmed pregnant; - Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled procedure; - Subjects uncertain about ending fertility; - Subjects with an active upper or lower genital tract infection; - Subjects with gynecologic malignancy (suspected or known); - Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic); - Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization; - Subjects with unexplained vaginal bleeding.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations New Horizons Women's Care Chandler, United States, 85224 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Visions Clinical Research - Tucson Tucson, United States, 85712 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Brown Stone Clinical Trials, LLC Irving, United States, 75061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Southeast Texas Family Planning and Cancer Screening Houston, United States, 77074 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Office of Dr. Cindy Basinski, LLC Newburgh, United States, 47630 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Columbus OB-GYN/Radiant Research Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Complete Healthcare for Women, Inc. Columbus, United States, 43231 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Integrated Health Care, PC Grand Blanc, United States, 48439 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Health Advantage Fort Wayne, United States, 46825 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Tennessee Medical Center Knoxville, United States, 37920 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Horizon Research Group of Opelousas, LLC Eunice, United States, 70535 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations OB-GYN Centre of Excellence Chattanooga, United States, 37404 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tufts Medical Center Boston, United States, 02111 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Health Alliance Raleigh, United States, 27607 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Amy Brenner, MD & Associates, LLC Mason, United States, 45040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations John H Stroger Jr. Hospital of Cook County Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Health Care Group of PA Pottstown, United States, 19464 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MetroHealth Medical Center Cleveland, United States, 44109-1998 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Health Care, PC Newburgh, United States, 47630 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Brown Stone Clinical Trials, LLC Irving, United States, 75061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Woman's Hospital of Texas Houston, United States, 77054 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wake Forest Baptist Health Winston-Salem, United States, 27157-1009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jersey Shore University Medical Center Neptune, United States, 07753 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Oklahoma University Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Kentucky Albert B. Chandler Hospital Lexington, United States, 40536-0001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wright State Physicians Health Center Dayton, United States, 45405-4534 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Columbia University Medical Center New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IU Health University Hospital Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AC Clinical Research Tiffin, United States, 44883-2820 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Reading Hospital West Reading, United States, 19611 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations United Clinical Research Huntington Beach, United States, 90255 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Women's Health Group, P.C. Thornton, United States, 80229-4388 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Luke's Hospital - Allentown Campus Allentown, United States, 18104-9701 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Precision Trials, AZ, LLC Phoenix, United States, 85032 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ben Taub General Hospital Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HWC Women’s Research Center Englewood, United States, 45322 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HillTop Obstetrics & Gynecology Franklin, United States, 45005-2593 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tanner Clinic Layton, United States, 84041-8803 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Physician Care Clinical Research Sarasota, United States, 34239 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tidewater Clinical Research, Inc. Virginia Beach, United States, 23456 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women & Infants Hospital (OGCC) Providence, United States, 02905 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seven Hills Women's Health Centers Cincinnati, United States, 45242 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Palmetto Clinical Research (PCR) Charleston, United States, 29406-9126 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women's Clinical Research Winston Salem, United States, 27103-1749 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eclipse Clinical Research Tuscon, United States, 85745-2696 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ohio State University Columbus, United States, 43210 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Research Prime, LLLP Idaho Falls, United States, 83402-3344 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women's Clinical Research, LLC Greensboro, United States, 27401-1207 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mid-Atlantic Permanente Research Institute Rockville, United States, 20852 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Baptist Health Center for Clinical Research Little Rock, United States, 72205-6325 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Healthcare Associates, LLC - Tualatin Pleasant Grove, United States, 84062-4097 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Orange Coast Women's Medical Group - Laguna Hills Office Laguna Hills, United States, 92653 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Physicians Research Options, LLC Lakewood, United States, 80228 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Altus Research Lake Worth, United States, 33461 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations M & O Clinical Research, LLC Ft. Lauderdale, United States, 33316 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universal Axon Clinical Research Miami, United States, 33166 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Oregon Health and Science University Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Iowa Clinic, PC West Des Moines, United States, 50266-8289 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
An open-label, non-randomized, prospective observational cohort study to assess post-procedural outcomes in two cohorts of women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization
Trial Type:
Interventional
Intervention Type:
Procedure/Surgery
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Pain: The proportion of AEs of chronic lower abdominal and/or pelvic pain after insertion of Essure System compared to the proportion of AEs of chronic lower abdominal and/or pelvic pain after laparoscopic tubal sterilizationAll AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.Timeframe: Up to 60 months
- Bleeding: The proportion of AEs of abnormal uterine bleeding (AUB) after insertion of Essure System compared to the proportion of AEs of AUB after laparoscopic tubal sterilizationAll AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.Timeframe: Up to 60 months
- Hypersensitivity / allergy / autoimmune disorders: The proportion of subjects with new onset or worsening allergic/hypersensitivity reactions and newly diagnosed or worsening autoimmune disorders in Essure vs laparoscopic tubal sterilization armsAll AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.Timeframe: Up to 60 months
- Proportion of subjects undergoing invasive gynecologic surgery after Essure placement (excluding second placement attempts), including Essure removal compared to subjects undergoing invasive gynecologic surgery after laparoscopic tubal sterilizationAll AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.Timeframe: Up to 60 months
- Patient reported outcomes for health statusMedical Outcomes Study Short Form-36Timeframe: Up to 60 months
- Patient reported outcomes for pain intensityPatient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Intensity 3a´. Pain intensity is assessed via questions and ranked across 5 levels from ´No pain´ to ´Very severe pain´.Timeframe: Up to 60 months
- Patient reported outcomes for pain interferencePatient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Interference 8a´. Pain interference is assessed via questions and ranked across 5 levels from ´Not at all´ to ´Very much´.Timeframe: Up to 60 months
- Patient reported outcomes for bleeding by AMSSAberdeen Menorrhagia Severity Scale (AMSS) is used to characterize bleeding. AMSS is a questionaire consisting of 13 items giving a total score from 0 (least severe) to 42 points (most severe).Timeframe: Up to 60 months
- Patient reported outcomes for bleeding by intermenstrual bleeding questionsTwo questions used to characterize intermenstrual bleeding.Timeframe: Up to 60 months
- Patient reported outcomes for centralized painAssessed with the Fibromyalgia Survey QuestionnaireTimeframe: At baseline
- Patient reported outcomes on adverse events from device reportsAssessed by questionnaires to actively solicit information on adverse events found in medical device reporting (MDR) reports with Essure and control potential bias in adverse event reporting.Timeframe: Up to 60 months
- Patient reported outcomes on media sources for their medical decisioningAssessed by Social Media questionnaire to elicit information about sources of influence on medical decisions.Timeframe: Up to 60 months
- Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilizationAll AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.Timeframe: Up to 60 months
Additional Information
Copyright © Bayer
Powered by
