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ThermaChoice III Under Local Sedation in the Office Setting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420264
First Posted: January 11, 2007
Last Update Posted: August 14, 2013
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ethicon, Inc.
Information provided by:
Female Pelvic Medicine & Urogynecology Institute of Michigan
  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 Intervention
Heavy Uterine Bleeding Device: Uterine Ablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tolerability of Uterine Ablation in the office setting [ Time Frame: 30 days ]

Enrollment: 21
Study Start Date: November 2005
Study Completion Date: May 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Uterine Ablation
    Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation
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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420264


Locations
United States, Michigan
Grand Valley Gynecologists, PC
Grand Rapids, Michigan, United States, 49506
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

Responsible Party: Jason B. Bennett, MD, Female Pelvic Medicine & Urogynecology Institute of Michigan
ClinicalTrials.gov Identifier: NCT00420264     History of Changes
Other Study ID Numbers: ThermaChoice III
First Submitted: January 10, 2007
First Posted: January 11, 2007
Last Update Posted: August 14, 2013
Last Verified: August 2013

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