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ThermaChoice III Under Local Sedation in the Office Setting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Female Pelvic Medicine & Urogynecology Institute of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by:
Female Pelvic Medicine & Urogynecology Institute of Michigan
ClinicalTrials.gov Identifier:
NCT00420264
First received: January 10, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.


Condition
Heavy Uterine Bleeding

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation

Resource links provided by NLM:

MedlinePlus related topics: Vaginal Bleeding
U.S. FDA Resources

Further study details as provided by Female Pelvic Medicine & Urogynecology Institute of Michigan:

Estimated Enrollment: 20
Study Start Date: November 2005
Estimated Study Completion Date: June 2007
Detailed Description:

A safe and effective treatment , called endometrial ablation, has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding. This study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication. This study will include twenty patients.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Heavy uterine bleeding

Exclusion Criteria:

  • Uterine or cervical cancer
  • Unable to tolerate office hysteroscopy
  • Uterine fibroid tumors that distort endometrial cavity
  • Uterine cavity greater than 12 cm
  • Patients with hyperplasia or premalignant changes of the endometrium
  • Active genital or urinary tract infections
  • Intrauterine device
  • Pregnant or want to become pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420264

Contacts
Contact: Jason B Bennett, MD 616-774-0700 bennettjb@gvgobgyn.com
Contact: Douglas M Van Drie, MD 616-774-0700 vandriedm@gvgobgyn.com

Locations
United States, Michigan
Grand Valley Gynecologists, PC Recruiting
Grand Rapids, Michigan, United States, 49506
Contact: Douglas M Van Drie, MD     616-774-0700     vandriedm@gvgobgyn.com    
Contact: Beth V Rogers, RN     616-774-0700     rogersbv@gvgobgyn.com    
Principal Investigator: Jason B Bennett, MD            
Sponsors and Collaborators
Female Pelvic Medicine & Urogynecology Institute of Michigan
Ethicon, Inc.
Investigators
Principal Investigator: Jason B Bennett, MD Grand Valley Gynecologists, PC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00420264     History of Changes
Other Study ID Numbers: ThermaChoice III
Study First Received: January 10, 2007
Last Updated: January 10, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013