Clinical trial NCT03127722: Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 990
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: 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 sterilization
timeFrame: Up to 60 months
measure: 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 sterilization
timeFrame: Up to 60 months
measure: 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 arms
timeFrame: Up to 60 months
measure: 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 sterilization
timeFrame: Up to 60 months
measure: Patient reported outcomes for health status
timeFrame: Up to 60 months
measure: Patient reported outcomes for pain intensity
timeFrame: Up to 60 months
measure: Patient reported outcomes for pain interference
timeFrame: Up to 60 months
measure: Patient reported outcomes for bleeding by AMSS
timeFrame: Up to 60 months
measure: Patient reported outcomes for bleeding by intermenstrual bleeding questions
timeFrame: Up to 60 months
measure: Patient reported outcomes for centralized pain
timeFrame: At baseline
measure: Patient reported outcomes on adverse events from device reports
timeFrame: Up to 60 months
measure: Patient reported outcomes on media sources for their medical decisioning
timeFrame: Up to 60 months
measure: Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilization
timeFrame: Up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: New Horizons Women's Care
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials, AZ, LLC
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Huntington Beach
country: United States
facility: United Clinical Research
state: California
city: Laguna Hills
country: United States
facility: Orange Coast Women's Medical Group - Laguna Hills Office
state: California
city: Lakewood
country: United States
facility: Physicians Research Options, LLC
state: Colorado
city: Thornton
country: United States
facility: The Women's Health Group, P.C.
state: Colorado
city: Fort Lauderdale
country: United States
facility: M & O Clinical Research, LLC
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime, LLLP
state: Idaho
city: Chicago
country: United States
facility: John H Stroger Jr. Hospital of Cook County
state: Illinois
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: Newburgh
country: United States
facility: Office of Dr. Cindy Basinski, LLC
state: Indiana
city: Newburgh
country: United States
facility: Women's Health Care, PC
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Albert B. Chandler Hospital
state: Kentucky
city: Eunice
country: United States
facility: Horizon Research Group of Opelousas, LLC
state: Louisiana
city: Rockville
country: United States
facility: Mid-Atlantic Permanente Research Institute
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Grand Blanc
country: United States
facility: Women's Integrated Health Care, PC
state: Michigan
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Greensboro
country: United States
facility: Unified Women's Clinical Research, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Women's Health Alliance
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: Seven Hills Women's Health Centers
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Columbus OB-GYN/Radiant Research
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women, Inc.
state: Ohio
city: Dayton
country: United States
facility: Wright State Physicians Health Center
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Franklin
country: United States
facility: HillTop Obstetrics & Gynecology
state: Ohio
city: Mason
country: United States
facility: Amy Brenner, MD & Associates, LLC
state: Ohio
city: Tiffin
country: United States
facility: AC Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Allentown
country: United States
facility: St. Luke's Hospital - Allentown Campus
state: Pennsylvania
city: Pottstown
country: United States
facility: Women's Health Care Group of PA
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital (OGCC)
state: Rhode Island
city: Charleston
country: United States
facility: Palmetto Clinical Research (PCR)
state: South Carolina
city: Chattanooga
country: United States
facility: OB-GYN Centre of Excellence
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
city: Houston
country: United States
facility: Southeast Texas Family Planning and Cancer Screening
state: Texas
city: Irving
country: United States
facility: Brown Stone Clinical Trials, LLC
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Pleasant Grove
country: United States
facility: Women's Healthcare Associates, LLC - Tualatin
state: Utah
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: