Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

NACompletedINTERVENTIONAL
Enrollment

990

Participants

Timeline

Start Date

May 3, 2017

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Contraception
Interventions
PROCEDURE

Blood draw

Decision for either treatment will be based upon clinical practice and physician/patient counseling. In addition of routine care practice, blood draws will be performed at baseline, 12 months and 60 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization.

DEVICE

ESSURE (BAY1454032)

Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.

PROCEDURE

Laparoscopic tubal sterilization

Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.

Trial Locations (57)

10032

Columbia University Medical Center, New York

19464

Women's Health Care Group of PA, Pottstown

19611

Reading Hospital, West Reading

20852

Mid-Atlantic Permanente Research Institute, Rockville

23456

Tidewater Clinical Research, Inc., Virginia Beach

27607

Women's Health Alliance, Raleigh

33166

Universal Axon Clinical Research, Miami

33316

M & O Clinical Research, LLC, Fort Lauderdale

33461

Altus Research, Lake Worth

34239

Physician Care Clinical Research, Sarasota

37404

OB-GYN Centre of Excellence, Chattanooga

37920

University of Tennessee Medical Center, Knoxville

43210

Ohio State University, Columbus

43213

Columbus OB-GYN/Radiant Research, Columbus

43231

Complete Healthcare for Women, Inc., Columbus

45040

Amy Brenner, MD & Associates, LLC, Mason

45242

Seven Hills Women's Health Centers, Cincinnati

45322

HWC Women's Research Center, Englewood

46202

IU Health University Hospital, Indianapolis

46825

Women's Health Advantage, Fort Wayne

47630

Office of Dr. Cindy Basinski, LLC, Newburgh

Women's Health Care, PC, Newburgh

48439

Women's Integrated Health Care, PC, Grand Blanc

60612

John H Stroger Jr. Hospital of Cook County, Chicago

70535

Horizon Research Group of Opelousas, LLC, Eunice

73104

Oklahoma University, Oklahoma City

75061

Brown Stone Clinical Trials, LLC, Irving

77030

Ben Taub General Hospital, Houston

77054

The Woman's Hospital of Texas, Houston

77074

Southeast Texas Family Planning and Cancer Screening, Houston

80228

Physicians Research Options, LLC, Lakewood

85032

Precision Trials, AZ, LLC, Phoenix

85224

New Horizons Women's Care, Chandler

85712

Visions Clinical Research - Tucson, Tucson

90255

United Clinical Research, Huntington Beach

92653

Orange Coast Women's Medical Group - Laguna Hills Office, Laguna Hills

97239

Oregon Health and Science University, Portland

85745-2696

Eclipse Clinical Research, Tucson

72205-6325

Baptist Health Center for Clinical Research, Little Rock

80229-4388

The Women's Health Group, P.C., Thornton

83402-3344

Clinical Research Prime, LLLP, Idaho Falls

50266-8289

The Iowa Clinic, PC, West Des Moines

40536-0001

University of Kentucky Albert B. Chandler Hospital, Lexington

02111

Tufts Medical Center, Boston

07753

Jersey Shore University Medical Center, Neptune City

27401-1207

Unified Women's Clinical Research, LLC, Greensboro

27103-1749

Unified Women's Clinical Research, Winston-Salem

27157-1009

Wake Forest Baptist Health, Winston-Salem

44109-1998

MetroHealth Medical Center, Cleveland

45405-4534

Wright State Physicians Health Center, Dayton

45005-2593

HillTop Obstetrics & Gynecology, Franklin

44883-2820

AC Clinical Research, Tiffin

18104-9701

St. Luke's Hospital - Allentown Campus, Allentown

02905

Women & Infants Hospital (OGCC), Providence

29406-9126

Palmetto Clinical Research (PCR), Charleston

84041-8803

Tanner Clinic, Layton

84062-4097

Women's Healthcare Associates, LLC - Tualatin, Pleasant Grove

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT03127722 - Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization | Biotech Hunter | Biotech Hunter