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ThermaChoice III Under Local Sedation in the Office Setting

This study has been completed.
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: August 13, 2013
Last verified: August 2013
  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: 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 ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 10, 2007
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 19, 2014